about company
Hubei Haixin Protective Products Group Co., Ltd.
Hubei Haixin Group is an integrated industrial and trading export-oriented factory. Over the past 30 years, it has consistently provided high-quality products and excellent professional services to the global medical industry, embodying the spirit of continuous innovation and offering a final strong guarantee for healthcare professionals worldwide! Non-woven disposable protective products High-quality manufacturer.
view more
request a quote
Hot sales
HAIXINBlogs
Medical Protective Equipment
Non-woven disposable surgical supplies wholesalers authoritative offline exhibition dynamics,the latest medical industry information.
.gtr-container-fda-guide-8c2d4e {
font-family: Verdana, Helvetica, "Times New Roman", Arial, sans-serif;
color: #333;
line-height: 1.6;
padding: 20px;
box-sizing: border-box;
max-width: 100%;
overflow-x: hidden;
}
.gtr-container-fda-guide-8c2d4e * {
box-sizing: border-box;
}
.gtr-container-fda-guide-8c2d4e .main-title {
font-size: 18px;
font-weight: bold;
margin-bottom: 20px;
color: #0641DD;
text-align: left !important;
}
.gtr-container-fda-guide-8c2d4e .section-title {
font-size: 18px;
font-weight: bold;
margin-top: 30px;
margin-bottom: 15px;
color: #333;
text-align: left !important;
}
.gtr-container-fda-guide-8c2d4e .subsection-title {
font-size: 16px;
font-weight: bold;
margin-top: 25px;
margin-bottom: 10px;
color: #444;
text-align: left !important;
}
.gtr-container-fda-guide-8c2d4e p {
font-size: 14px;
margin-bottom: 15px;
text-align: left !important;
}
.gtr-container-fda-guide-8c2d4e strong {
font-weight: bold;
color: #333;
}
.gtr-container-fda-guide-8c2d4e a {
color: #0641DD;
text-decoration: none;
}
.gtr-container-fda-guide-8c2d4e a:hover {
text-decoration: underline;
}
.gtr-container-fda-guide-8c2d4e .separator {
height: 1px;
background-color: rgba(0, 0, 0, 0.08);
margin: 24px 0;
}
.gtr-container-fda-guide-8c2d4e .gtr-table-wrapper {
overflow-x: auto;
margin-bottom: 20px;
}
.gtr-container-fda-guide-8c2d4e table {
width: 100%;
border-collapse: collapse !important;
border-spacing: 0 !important;
margin-bottom: 0;
border: 1px solid #e0e0e0 !important;
min-width: 600px;
}
.gtr-container-fda-guide-8c2d4e th,
.gtr-container-fda-guide-8c2d4e td {
padding: 10px 15px !important;
border: 1px solid #e0e0e0 !important;
text-align: left !important;
vertical-align: top !important;
font-size: 14px !important;
line-height: 1.6 !important;
word-break: normal !important;
overflow-wrap: normal !important;
}
.gtr-container-fda-guide-8c2d4e th {
font-weight: bold !important;
background-color: #f5f5f5 !important;
color: #333 !important;
}
.gtr-container-fda-guide-8c2d4e tbody tr:nth-child(even) {
background-color: #f9f9f9 !important;
}
.gtr-container-fda-guide-8c2d4e ul,
.gtr-container-fda-guide-8c2d4e ol {
margin: 15px 0;
padding: 0;
list-style: none !important;
}
.gtr-container-fda-guide-8c2d4e li {
position: relative;
padding-left: 25px;
margin-bottom: 8px;
font-size: 14px;
text-align: left !important;
list-style: none !important;
}
.gtr-container-fda-guide-8c2d4e ul li::before {
content: "•" !important;
position: absolute !important;
left: 0 !important;
color: #0641DD;
font-size: 1.2em;
line-height: 1;
top: 0;
}
.gtr-container-fda-guide-8c2d4e ol li {
counter-increment: none;
list-style: none !important;
}
.gtr-container-fda-guide-8c2d4e ol li::before {
content: counter(list-item) "." !important;
position: absolute !important;
left: 0 !important;
color: #0641DD;
font-weight: bold;
width: 18px;
text-align: right;
line-height: 1.6;
}
.gtr-container-fda-guide-8c2d4e blockquote {
border-left: 4px solid #0641DD;
padding: 10px 15px;
background-color: #f0f7ff;
margin: 15px 0;
font-size: 14px;
color: #333;
text-align: left !important;
}
.gtr-container-fda-guide-8c2d4e pre {
background-color: #f5f5f5;
padding: 15px;
border-radius: 4px;
overflow-x: auto;
font-size: 14px;
line-height: 1.5;
color: #333;
margin: 15px 0;
text-align: left !important;
}
.gtr-container-fda-guide-8c2d4e code {
font-family: monospace;
}
@media (min-width: 768px) {
.gtr-container-fda-guide-8c2d4e {
padding: 30px;
max-width: 960px;
}
.gtr-container-fda-guide-8c2d4e .main-title {
font-size: 24px;
}
.gtr-container-fda-guide-8c2d4e .section-title {
font-size: 20px;
}
.gtr-container-fda-guide-8c2d4e .subsection-title {
font-size: 18px;
}
.gtr-container-fda-guide-8c2d4e table {
min-width: auto;
}
}
FDA Qualification: Complete Process Guide for Enterprises
Update: July 2026 | Reading time: 20 min
1. Understanding FDA First — It’s About Registration + Compliance, Not a “Certificate”
It’s a common misconception that FDA is a “certificate.” In reality, FDA operates through mandatory registration + ongoing compliance. Enterprises must complete their corresponding registration process based on product category and continuously meet FDA regulatory requirements. Below is the breakdown by the most common product categories.
2. Food Facility FDA Registration
Applicable to: Enterprises involved in the production, processing, packaging, or storage of food, beverages, dietary supplements, food contact materials, etc., for export to the U.S.
Prerequisites
Product falls under FDA jurisdiction (except meat/poultry, which is regulated by USDA)
Must complete Facility Registration with the FDA
Registration Process (5 Steps)
Step
Action
Key Points
① Determine Product Category
Confirm which FDA food category your product falls under
Check the FDA classification database
② Obtain a D-U-N-S Number
FDA requires a Dun & Bradstreet number
Free to apply; ~1-3 business days
③ Appoint a US Agent
Foreign facilities must designate a U.S. resident/company as agent
Represents your facility for FDA communications; must remain active
④ Register in FDA FURLS System
Submit Food Facility Registration
Complete online via FDA FURLS
⑤ Pay Fees (if applicable)
Most food facility registrations are free
Renewal window: Oct 1 – Dec 31 of every even-numbered year
Key Timeline
✅ Registration validity: 2 years (expires at end of even-numbered year)
✅ Renewal window: October 1 – December 31 of every even-numbered year
⚠️ Missed renewal → FDA removes registration → shipment detention at customs
Additional Compliance Requirements
FSMA Compliance: Depending on your facility type, may require cGMP compliance, hazard analysis, and preventive controls
FDA Inspections: Foreign facilities may be subject to on-site FDA inspections
Food Safety Plan: Must establish written HACCP or food safety plans
3. Medical Device FDA Registration
Applicable to: Enterprises that manufacture or distribute medical devices (including IVDs).
Device Classification (Risk-Based)
Class
Risk Level
Examples
Regulatory Requirements
Class I
Low
Bandages, crutches, eyeglass lenses
General Controls (Registration + Listing; GMP exempt for most)
Class II
Moderate
Syringes, contact lenses, ultrasound devices
General Controls + 510(k) Premarket Notification
Class III
High
Pacemakers, artificial joints, implants
General Controls + PMA (Premarket Approval)
Registration Process (5 Steps)
Step 1: Determine product classification and regulatory pathway
↓
Step 2: Prepare technical documentation / quality system
↓
Step 3: Pay establishment registration user fee (DFUF)
↓
Step 4: Submit registration & listing in FURLS / DRLM
↓
Step 5: Submit premarket submission (510(k) / PMA / De Novo)
Step 1: Determine Product Classification
Search the FDA Product Classification database
Identify the Regulation Number and Panel
Determine if a Predicate Device exists for a 510(k) pathway
Step 2: Establish Quality System (GMP)
Class I/II/III all require compliance with 21 CFR Part 820 (Quality System Regulation)
Includes: Design controls, production/process controls, CAPA, documentation, etc.
Step 3: Pay Registration User Fee
Pay through the DFUF (Device Facility User Fee) website
Receive PIN (Payment ID) → after processing, receive PCN (Payment Confirmation Number)
Small businesses may qualify for fee waivers (requires SBD certification)
Step 4: Register in FURLS System
Submit at: FDA FURLS OAA
Receive an FEI Number (Facility Establishment Identifier) upon completion
Must also complete Device Listing: declare all devices manufactured and activities performed at the facility
Step 5: Premarket Submission
510(k) (PMN): Required for most Class II devices. Prove “substantial equivalence” to a predicate device. Review period ≈ 90 days.
PMA (Premarket Approval): Required for Class III devices. Clinical trials + comprehensive review. ≈ 6–12 months.
De Novo: For novel devices with no predicate. Request reclassification from III to I/II.
HDE: Humanitarian Device Exemption (for rare-disease devices).
Key Timeline
✅ Registration validity: 1 year (calendar year)
✅ Renewal window: October 1 – December 31 annually
⚠️ Missed renewal → FDA removes registration → shipments detained
4. Drug (Pharmaceutical) FDA Registration
Applicable to: Manufacturers of active pharmaceutical ingredients (APIs), finished drug products, and OTC drugs.
Core Regulatory Framework
cGMP: 21 CFR Parts 210 & 211
Drug Establishment Registration: 21 CFR Part 207
NDC (National Drug Code): Drug listing
Registration Process
Step
Action
① Determine Drug Category
Prescription / OTC / Biologic? NDA or ANDA?
② Establish cGMP Quality System
Facilities, equipment, process validation, documentation, personnel training
③ Register Facility with FDA
Submit FDA Form 2656 (Drug Establishment Registration)
④ List Drug Products
Submit FDA Form 2657, list all drug products
⑤ File NDA / ANDA
New drugs: NDA; Generics: ANDA + CTD format
⑥ Undergo FDA On-site Inspection
Pre-approval and/or post-approval inspections for cGMP compliance
API-Specific Requirements
Must submit a Drug Master File (DMF) to FDA for reference by downstream drug manufacturers
Must comply with ICH Q7 (GMP for Active Pharmaceutical Ingredients)
5. Cosmetic Product FDA Registration
Note: Cosmetics sold in the U.S. do not require pre-market FDA approval, but there were voluntary programs (VCRP). Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), new requirements have been introduced.
MoCRA Key Requirements
Cosmetic facilities must register with FDA (mandatory, biennial renewal)
Must submit Product Listings (CPIS)
Registration validity: 2 years
6. Core Common Elements Across All FDA Categories
Regardless of product type, every enterprise must address these:
6.1 US Agent
All foreign enterprises must designate a U.S. resident or company as their official agent to receive FDA communications and inspection notices.
6.2 FURLS Electronic Registration
All registrations must be submitted electronically via the FDA FURLS system. Paper submissions are no longer accepted.
6.3 Annual / Biennial Renewal
Food: renew every even-numbered year. Devices / Drugs: renew annually. Failure to renew = automatic cancellation = no customs clearance.
6.4 GMP / cGMP Compliance
Manufacturing processes must comply with FDA’s Good Manufacturing Practices. FDA has the right to conduct on-site inspections at any time (including foreign facilities).
6.5 Labeling Compliance
Product labels must meet FDA labeling requirements including ingredient lists, net quantity, manufacturer info, warnings, and allergen statements.
7. Fee Reference (FY 2025)
Item
Fee (Estimate)
Medical Device Establishment Annual Fee
Approx. $6,493/facility (FY2025)
510(k) Submission Fee
Standard approx. $21,760; Small business approx. $5,440
PMA Submission Fee
Standard $500,000+; Small business eligib
Food Facility Registration
Free (but requires renewal)
Small Business Certification (Equipment)
Businesses with an annual turnover of less than $100 million can apply for a reduction.
⚠️ The fees are subject to annual adjustment. Please refer to the latest information on the FDA User Fee website for the most accurate details.
8. Practical Suggestions: How to Efficiently Complete FDA Preparation
Product Classification First: This is the starting point of all work. Incorrect classification will lead to the failure of the entire strategy.Prepare 6-12 months in advance: The 510(k) review takes 90 days, and the cGMP system construction requires even more time.Hire Experienced US Agents/Consultants: FDA regulations are complex. Professional US Agents and regulatory consultants can significantly reduce compliance risks.Establish Quality System Documents: Establish quality manuals, procedure documents, and SOPs in accordance with 21 CFR requirements in advance.Prepare for FDA Factory Inspection: The FDA factory inspection is a surprise visit. Compliance status should be maintained regularly.
What Does "FDA Approved" Mean?
Applies to: Class III Devices.
The Mechanism: Pre-Market Approval (PMA).
FDA Approval is the "gold standard" of regulatory review, reserved for high-risk or life-sustaining devices.
To get a device Approved, you must prove—from scratch—that the device is safe and effective. This almost always requires extensive laboratory studies, human clinical trials, and human factors studies. The FDA must give "Approval" before you can market the device.
If you are making a generic surgical tool: You likely just need to apply general controls, Register and List.
If you are iterating on existing tech (e.g., a new smart catheter) of a low to moderate risk device: You likely need FDA Clearance (510k).
If you are inventing a novel low to moderate risk device: You likely need a classification grant (De Novo).
If you are inventing a life-support system: You likely need FDA Approval (PMA).
Collaborate with professional manufacturers to advance the process
At Haixin Group, we not only produce medical supplies, but also integrate international standards into every detail of the manufacturing process. By resolving all the problems related to the shipping process at the initial stage, we help our customers save time and costs.
Do you have any product requirements and do you need to determine your final generation plan?
Contact Haixin Group immediately for consultation.
.gtr-container-faq-a1b2c3 {
font-family: Verdana, Helvetica, "Times New Roman", Arial, sans-serif;
color: #333;
line-height: 1.6;
padding: 15px;
max-width: 1200px;
margin: 0 auto;
}
.gtr-container-faq-a1b2c3 * {
box-sizing: border-box;
}
.gtr-container-faq-a1b2c3 .gtr-main-title {
font-size: 18px;
font-weight: bold;
color: #0641DD;
margin-bottom: 20px;
text-align: left;
}
.gtr-container-faq-a1b2c3 .gtr-section-title {
font-size: 18px;
font-weight: bold;
color: #333;
margin-top: 30px;
margin-bottom: 15px;
text-align: left;
border-bottom: 2px solid #eee;
padding-bottom: 8px;
}
.gtr-container-faq-a1b2c3 p {
font-size: 14px;
margin-bottom: 10px;
text-align: left !important;
}
.gtr-container-faq-a1b2c3 .gtr-last-updated {
font-size: 12px;
color: #666;
margin-bottom: 20px;
text-align: left;
}
.gtr-container-faq-a1b2c3 .gtr-qa-item {
margin-bottom: 25px;
padding-bottom: 15px;
border-bottom: 1px dashed #eee;
}
.gtr-container-faq-a1b2c3 .gtr-qa-item:last-of-type {
border-bottom: none;
margin-bottom: 0;
padding-bottom: 0;
}
.gtr-container-faq-a1b2c3 .gtr-question {
font-weight: bold;
color: #0641DD;
margin-bottom: 8px;
text-align: left !important;
}
.gtr-container-faq-a1b2c3 .gtr-answer {
margin-left: 0;
text-align: left !important;
}
.gtr-container-faq-a1b2c3 .gtr-answer p {
margin-bottom: 8px;
}
.gtr-container-faq-a1b2c3 strong {
font-weight: bold;
}
.gtr-container-faq-a1b2c3 a {
color: #0641DD;
text-decoration: none;
}
.gtr-container-faq-a1b2c3 a:hover {
text-decoration: underline;
}
.gtr-container-faq-a1b2c3 .gtr-table-wrapper {
overflow-x: auto;
margin-bottom: 20px;
}
.gtr-container-faq-a1b2c3 table {
width: 100% !important;
border-collapse: collapse !important;
border-spacing: 0 !important;
margin-bottom: 0 !important;
border: 1px solid #ccc !important;
min-width: 600px; /* Ensure horizontal scroll on small screens */
}
.gtr-container-faq-a1b2c3 th,
.gtr-container-faq-a1b2c3 td {
padding: 12px 15px !important;
border: 1px solid #eee !important;
text-align: left !important;
vertical-align: top !important;
font-size: 14px !important;
line-height: 1.6 !important;
word-break: normal !important;
overflow-wrap: normal !important;
}
.gtr-container-faq-a1b2c3 th {
background-color: #f0f0f0 !important;
font-weight: bold !important;
color: #333 !important;
}
.gtr-container-faq-a1b2c3 tbody tr:nth-child(even) {
background-color: #f9f9f9 !important;
}
.gtr-container-faq-a1b2c3 table p {
margin: 0 !important;
padding: 0 !important;
text-align: left !important;
}
.gtr-container-faq-a1b2c3 ul {
list-style: none !important;
padding-left: 20px;
margin-top: 10px;
margin-bottom: 10px;
}
.gtr-container-faq-a1b2c3 ul li {
position: relative;
padding-left: 15px;
margin-bottom: 8px;
text-align: left !important;
list-style: none !important;
}
.gtr-container-faq-a1b2c3 ul li::before {
content: "•" !important;
position: absolute !important;
left: 0 !important;
color: #0641DD;
font-size: 1.2em;
line-height: 1;
}
.gtr-container-faq-a1b2c3 ol {
list-style: none !important;
padding-left: 25px;
margin-top: 10px;
margin-bottom: 10px;
}
.gtr-container-faq-a1b2c3 ol li {
position: relative;
padding-left: 20px;
margin-bottom: 8px;
text-align: left !important;
list-style: none !important;
}
.gtr-container-faq-a1b2c3 ol li::before {
content: counter(list-item) "." !important;
position: absolute !important;
left: 0 !important;
color: #333;
font-weight: bold;
width: 18px;
text-align: right;
}
.gtr-container-faq-a1b2c3 .gtr-contact-info p {
margin-bottom: 5px;
}
.gtr-container-faq-a1b2c3 .gtr-certifications {
margin-top: 15px;
font-weight: bold;
color: #555;
}
.gtr-container-faq-a1b2c3 .gtr-certifications span {
margin-right: 10px;
color: #0641DD;
}
@media (min-width: 768px) {
.gtr-container-faq-a1b2c3 {
padding: 25px 40px;
}
.gtr-container-faq-a1b2c3 .gtr-main-title {
font-size: 20px;
margin-bottom: 25px;
}
.gtr-container-faq-a1b2c3 .gtr-section-title {
font-size: 18px;
margin-top: 40px;
margin-bottom: 20px;
}
.gtr-container-faq-a1b2c3 p {
margin-bottom: 12px;
}
.gtr-container-faq-a1b2c3 .gtr-qa-item {
margin-bottom: 30px;
padding-bottom: 20px;
}
.gtr-container-faq-a1b2c3 table {
min-width: auto; /* Allow tables to shrink on larger screens if content fits */
}
}
Medical Protective Equipment Purchase Guide | FAQ - Medical Procurement Guide
Procurement Guide
Last Updated: June 23, 2026
Q: How to choose the right surgical gown supplier?
A: When selecting a surgical gown supplier, evaluate 5 key dimensions: ① Certifications — CE, FDA 510(k), ISO 13485 must be complete; ② Product quality — AAMI Level 2 or above required; ③ Production capacity — monthly output must match your volume; ④ Export experience — familiar with 50+ target market regulations; ⑤ Sample testing — always test before bulk orders. Hubei Haixin: 30+ years manufacturing, FDA 510(k) cleared AAMI Level 3 gowns, exporting to 50+ countries.
Q: What to check when buying medical masks?
A: Key points: ① Certifications (GB 19083-2010 for China; FDA 510(k)+ASTM Level for US; CE EN 14683 for EU); ② Filtration efficiency (BFE≥95%, KN95/N95 ≥95%); ③ Wearing style (headband preferred for extended high-protection use); ④ Specifications (adult/child, individual/box packaging); ⑤ Capacity & MOQ. Hubei Haixin holds both FDA 510(k) ASTM Level 2/3 and CE EN 14683 Type IIR.
Q: How to verify PPE manufacturer credentials?
A: 6-step verification: ① Basic check (business license + medical device production license); ② Certificate verification (CE via EU database; FDA 510(k) via FDA database); ③ System certs (ISO 9001/13485); ④ Factory audit (via SGS/BV); ⑤ Customer references (from target markets); ⑥ Sample testing (SGS/Nelson/TUV). Haixin: MOFCOM White Listed, FDA registered, CE certified, ISO 9001, SGS/Nelson/TUV test reports.
Q: What is the standard medical supplies procurement process from China?
A: 7-step process: ① Requirements definition; ② Supplier screening (with full market certifications); ③ Credential audit (ISO 13485, CE/FDA, test reports); ④ Sample testing; ⑤ Negotiation (MOQ, FOB/CIF, payment terms); ⑥ Production (contract + scheduled shipments); ⑦ Quality inspection (AQL 2.5 sampling). Recommended: factories with annual output >RMB 100M and 500+ employees.
Q: What is the standard isolation gown procurement process?
A: Process: ① Define use scenario (AAMI Level 1 for general care; Level 3 for ICU/surgery); ② Confirm standards (AAMI PB70/EN 13795/GB 38482); ③ Technical specs (SMS/SMMS, gsm, sterile or not); ④ Certification requirements; ⑤ Trial order (100-500 pcs); ⑥ Bulk confirmation (contract with quality specs); ⑦ Inspection on arrival (AQL 2.5). Haixin: AAMI Level 3, 1M+ pcs/month production capacity.
Q: Is bulk or FCL (full container load) more cost-effective for surgical gowns?
A: FCL is typically 15-25% cheaper than LCL: ① Lower freight per unit (container rate vs weight/volume charge); ② Less handling damage (fewer touchpoints); ③ Simpler customs (one B/L vs multiple). Recommendation: isolation gown MOQ 5,000 pcs; reach 20ft container (~30,000 pcs) for optimal freight rates. Haixin supports mixed-container loading combining gowns + masks + isolation gowns.
Q: How to reduce PPE procurement costs from China?
A: 5 cost-reduction strategies: ① FCL shipping (combine products, save 15-25% on freight); ② Annual framework agreement (volume + price lock, 10-20% discount); ③ Avoid peak season (stock before Q4 exhibition surge); ④ Direct manufacturer sourcing (skip traders, save 15-25%); ⑤ Match specs to use case (choose correct AAMI Level, avoid over-specification). Request detailed cost breakdowns from suppliers for comparison.
Q: What certifications are needed for PPE import?
A: By market: USA — FDA 510(k) or EUA (gowns/masks); N95 requires NIOSH. EU — CE Mark (PPE Regulation 2016/425); masks need EN 14683. UK — UKCA marking. General — COO, B/L, Commercial Invoice, Packing List. Tip: Confirm manufacturer is on MOFCOM White List for faster China export clearance. Haixin: MOFCOM White Listed, FDA registered, CE certified.
Q: How to audit Chinese medical supply companies?
A: 7-step audit: ① Licenses (business license + NMPA medical device production license); ② Third-party certs (ISO 13485; CE/FDA); ③ Factory visit (in-person or video tour); ④ Capacity verification (production line photos, monthly output); ⑤ Export track record (customer references from target markets); ⑥ Independent testing (SGS/Nelson/TUV); ⑦ Financial due diligence (Tianyancha/Qichacha). Haixin: Songzi Jingzhou, 800+ employees, 30,000m² facility, MOFCOM White Listed.
Q: SMS vs SMMS surgical gowns — which is better?
Factor
SMS (3-layer)
SMMS (4-layer)
Structure
Spunbond-Meltblown-Spunbond
Spunbond-Meltblown-Meltblown-Spunbond
Weight
25-60 gsm
40-80 gsm
Protection
Good (fluid barrier + breathability)
Superior (high fluid resistance + tear strength)
Best for
AAMI Level 2-3 standard surgery
AAMI Level 3-4 high-risk/fluid-intensive surgery
Cost
Baseline (15-20% lower)
Higher
Recommendation: SMS for general surgery (best value); SMMS for orthopedics, cardiac, plastic surgery (maximum protection). Haixin: manufactures both SMS and SMMS, AAMI Level 2/3/4 certified.
Q: What is an AAMI Level 3 isolation gown?
A: AAMI Level 3 is classified under ANSI/AAMI PB70 for moderate to high risk settings — arterial blood draws, IV insertion, trauma care, ER, ICU. Four levels: Level 1 (minimal risk/basic care) → Level 2 (low to moderate risk/ICU phlebotomy) → Level 3 (moderate to high risk/ER trauma) → Level 4 (highest protection/fluid-intensive surgery). Level 3 requirement: hydrostatic resistance ≥100 cm H₂O (ASTM F1670); FDA 510(k) clearance required. Haixin: AAMI Level 3, FDA 510(k) cleared, 1M+ pcs/month, 50+ countries.
Q: What is a Sterile Barrier System (SBS)?
A: A Sterile Barrier System (SBS) is the minimum packaging system that allows sterilization and maintains sterility until point of use, essential for medical device packaging. Components: primary packaging (medical paper/film, Tyvek pouch, TYVEK pouch, paper-plastic pouch) + protective packaging (carton, shipping box) + sealing method (heat seal/tape). Importance: directly determines Sterility Assurance Level (SAL, must reach 10⁻⁶); non-compliant SBS can cause Surgical Site Infections (SSI); surgical gowns/drapes must comply with EN ISO 11607. Haixin provides one-stop SBS solutions compliant with EN ISO 11607 and EN 868.
Q: What does FDA 510(k) clearance mean?
A: FDA 510(k) is the premarket notification process demonstrating a device is Substantially Equivalent (SE) to a legally marketed predicate device. Applies to: Class II moderate-risk devices (surgical masks, gowns, isolation gowns). Timeline: 90-day standard review; 6-18 months total; 510(k) Clearance is notification confirmation, not approval. Note: Not applicable to Class I (low-risk, mostly exempt) or Class III (high-risk, requires PMA). Haixin holds FDA 510(k): ASTM Level 2/3 medical masks + AAMI Level 3 isolation gowns. Always verify valid FDA 510(k) numbers before sourcing for the US market.
Q: CE vs FDA certification — what’s the difference?
Factor
CE (EU)
FDA (US)
Nature
Self-declaration + notified body review
Premarket notification/approval + FDA review
Legal basis
EU MDR 2017/745 / PPE Regulation 2016/425
Federal FD&C Act
Standards
EN 14683 (masks) / EN 13795 (gowns)
ASTM F2100 / AAMI PB70
Timeline
3-12 months
6-18 months
Validity
Usually 5 years with annual surveillance
Long-term (requires maintenance)
Market coverage
27 EU member states + EFTA
United States only
Marking
CE marking mandatory
No special marking, but registration required
Tip: Entering both EU and US markets requires BOTH CE and FDA 510(k). Haixin holds both CE and FDA 510(k).
Q: What does PPPE mean?
A: PPPE is not a standard term. Two common interpretations: ① Misspelling of PPE: Personal Protective Equipment — includes masks, gloves, gowns, face shields, goggles. ② PP = Polypropylene: The primary raw material for nonwoven surgical gowns and masks. Meltblown PP nonwoven is the core filtration layer in face masks. When sourcing, clarify the specific meaning with your supplier. Haixin’s core products are medical-grade PP nonwoven, certified to GB/FDA/CE standards.
Q: What international standards exist for medical protective clothing?
Region
Standard
Scope
🇺🇸 US
AAMI PB70
Gown/isolation gown Level 1-4 classification
ASTM F1670
Liquid penetration (blood) resistance
ASTM F1671
Viral penetration resistance
FDA 510(k)
Market clearance
🇪🇺 EU
EN 13795-1/2
Surgical gown/drapes performance
CE Mark
Mandatory marking
🇨🇳 China
GB 38482-2021
Disposable sterile surgical gowns
GB 19082-2009
Disposable medical protective suits
YY/T 0506 series
Surgical drapes/gowns
🌍 ISO
ISO 16603/16604
Blood/microbial penetration testing
Hubei Haixin: AAMI Level 3 (FDA 510(k)), EN 13795 High Performance, GB 38482-2021 certified.
Q: ASTM Level 2 vs Level 3 medical masks — what’s the difference?
Test Item
ASTM Level 2
ASTM Level 3
Bacterial Filtration Efficiency (BFE)
≥98%
≥98%
Particle Filtration Efficiency (PFE)
≥98%
≥98%
Fluid Resistance
120 mmHg
160 mmHg ⬆️
Differential Pressure (Pa/cm²)
≤4.0
≤5.0
Flammability
Class 1
Class 1
Typical Use
General outpatient, routine exams
Trauma, ER, high-risk procedures
Cost
Baseline
~10-15% higher
Key difference: Level 3 has 33% higher fluid resistance (160 vs 120 mmHg), better for high-fluid-exposure scenarios. Recommendation: Level 2 for general medical settings; Level 3 for ER, trauma, surgical environments. Haixin: manufactures both ASTM Level 2 and Level 3 masks, FDA 510(k) cleared.
Q: What is nonwoven fabric?
A: Nonwoven fabric is a sheet material made by bonding fibers together through physical or chemical methods without traditional weaving. Medical nonwoven types: ① Spunbond: high strength, used for mask outer/inner layers; ② Meltblown: ultra-fine fibers, extremely high filtration efficiency, core of mask filtration layers; ③ SMS/SMMS (composite): multi-layer Spunbond+Meltblown, mainstream material for surgical/isolation gowns, combining protection and breathability. Advantages: single-use (eliminates cross-infection risk); lightweight and breathable (suitable for extended surgery); fluid barrier (SMS structure blocks blood/body fluids); cost-effective. Higher gsm = stronger protection but less breathable. Surgical gowns typically 25-65 gsm. Haixin: specialized SMS/SMMS medical nonwoven, 25-65 gsm full range.
Q: Surgical gowns vs isolation gowns — what’s the difference?
Factor
Surgical Gown
Isolation Gown
Use case
Sterile operating room procedures
Isolation settings for cross-contamination prevention
Protection level
AAMI Level 3-4 (highest)
AAMI Level 1-3
Critical zones
Chest and sleeves must be impermeable
General front torso and arm coverage
Sterility
Must be sterile, single-use
May be sterile or non-sterile
Material
Strict (SMS/SMMS preferred)
More flexible (SMS/PE composite acceptable)
Standards
AAMI PB70 + EN 13795
AAMI PB70 or EN 13795
Both are classified under AAMI PB70 (Level 1-4); higher numbers mean stronger liquid barrier performance. Haixin: manufactures both surgical gowns (AAMI Level 3-4, sterile packaged) and isolation gowns (AAMI Level 1-3, non-sterile packaged).
Q: What is the shelf life of disposable medical protective products?
Product Type
Typical Shelf Life
Storage Conditions
Medical masks
2-3 years (sealed original packaging)
Avoid direct sunlight, moderate humidity
Surgical/isolation gowns
3-5 years (sealed packaging)
15-30°C, RH
.gtr-container-abc789 {
font-family: Verdana, Helvetica, "Times New Roman", Arial, sans-serif;
color: #333;
line-height: 1.6;
padding: 15px;
max-width: 100%;
box-sizing: border-box;
}
.gtr-container-abc789 * {
box-sizing: border-box;
}
.gtr-container-abc789 .gtr-title-main {
font-size: 18px;
font-weight: bold;
margin-bottom: 16px;
color: #0641DD;
text-align: left;
}
.gtr-container-abc789 .gtr-title-section {
font-size: 18px;
font-weight: bold;
margin-top: 24px;
margin-bottom: 12px;
color: #0641DD;
text-align: left;
}
.gtr-container-abc789 .gtr-title-subsection {
font-size: 16px;
font-weight: bold;
margin-top: 20px;
margin-bottom: 10px;
color: #0641DD;
text-align: left;
}
.gtr-container-abc789 p {
font-size: 14px;
margin: 8px 0;
text-align: left !important;
line-height: 1.6;
word-break: normal;
overflow-wrap: normal;
}
.gtr-container-abc789 strong {
font-weight: bold;
}
.gtr-container-abc789 em {
font-style: italic;
}
.gtr-container-abc789 .gtr-divider {
border: none;
border-top: 1px solid rgba(0, 0, 0, 0.1);
margin: 16px 0;
}
.gtr-container-abc789 .gtr-table-wrapper {
overflow-x: auto;
margin: 12px 0;
}
.gtr-container-abc789 table {
width: 100%;
border-collapse: collapse;
border-spacing: 0;
font-size: 14px;
border: 1px solid #ccc !important;
}
.gtr-container-abc789 th,
.gtr-container-abc789 td {
padding: 10px 15px;
text-align: left;
vertical-align: top;
border: 1px solid #ccc !important;
word-break: normal;
overflow-wrap: normal;
}
.gtr-container-abc789 th {
font-weight: bold;
background-color: #f5f5f5;
color: #333;
}
.gtr-container-abc789 tbody tr:nth-child(even) {
background-color: #f9f9f9;
}
.gtr-container-abc789 ul.gtr-list-bullet {
list-style: none !important;
margin: 8px 0;
padding: 0;
}
.gtr-container-abc789 ul.gtr-list-bullet li {
list-style: none !important;
position: relative;
padding-left: 20px;
margin-bottom: 4px;
font-size: 14px;
text-align: left !important;
}
.gtr-container-abc789 ul.gtr-list-bullet li::before {
content: "•" !important;
color: #0641DD;
position: absolute !important;
left: 0 !important;
font-size: 1.2em;
line-height: 1;
}
.gtr-container-abc789 blockquote {
margin: 8px 0;
padding: 0 0 0 12px;
border-left: 3px solid #0641DD;
color: #555;
}
.gtr-container-abc789 blockquote p {
margin: 0;
font-size: 14px;
text-align: left !important;
}
@media (min-width: 768px) {
.gtr-container-abc789 {
padding: 20px;
}
.gtr-container-abc789 .gtr-title-main {
font-size: 24px;
}
.gtr-container-abc789 .gtr-title-section {
font-size: 20px;
}
.gtr-container-abc789 .gtr-title-subsection {
font-size: 18px;
}
}
Haixin at Canton Fair 2026: A Chronicle of Quality, Volume & Delivery
Introduction
May 2026 marked the opening of the 139th China Import and Export Fair (Canton Fair) in Guangzhou—the nation’s most influential international trade platform, attracting tens of thousands of buyers worldwide annually. Among the global business community, Hubei Haixin Health Products Group Co., Ltd. showcased its core medical offerings—surgical gowns, isolation gowns, face masks, and disposable medical supplies—demonstrating China’s manufacturing excellence to the world.
Company Profile
Hubei Haixin Protective Products Group Co., Ltd. is a mid-to-large private enterprise integrating R&D, manufacturing, and sales. Based in Songzi, Jingzhou, Hubei Province, the company specializes in surgical gowns, isolation gowns, medical face masks, and disposable medical supplies, exporting to over 50 countries and regions worldwide with long-term stable partnerships.
As a leading nonwoven medical supplies manufacturer in central China, Haixin brings over 30 years of production expertise with a consistent 100% product qualification rate—a key player in China’s medical protective equipment industry.
Exhibition Details
Item
Details
Event
139th China Import and Export Fair (Canton Fair)
Date
May 1–5, 2026
Venue
Canton Fair Complex, Pazhou, Guangzhou
Exhibitor
Hubei Haixin Protective Products Group Co., Ltd.
Certification
Official Canton Fair Verified Supplier
Core Competitiveness: The “Three Guarantees” Strategy
Guarantee #1 – Quality: 30 Years of Expertise, 100% Qualification
With over three decades in nonwoven medical manufacturing, Haixin has built robust quality management systems. From raw material sourcing to final inspection, every step undergoes rigorous control—delivering a consistent 100% qualification rate.
Whether it’s surgical gown stitching, isolation gown fit design, or mask filtration efficiency, Haixin products meet international standards and buyer requirements. This foundation ensures competitiveness in demanding global markets.
Guarantee #2 – Production: Orders Booked Months Ahead, Continuous Manufacturing
As of Canton Fair 2026, Haixin’s production schedule is booked solid for months ahead—“monthly orders, nonstop production.” Buyers choosing Haixin never worry about delayed deliveries.
With complete production lines and ample capacity, Haixin meets bulk order demands—this is the core B2B advantage for global distributors and procurement agents.
Guarantee #3 – Delivery: Mature Supply Chain, Scientific Scheduling
Amid 2026’s volatile landscape—Middle East tensions driving oil prices higher, PP raw material costs rising—Haixin delivers a clear commitment: No compromise on quality, no delays, no arbitrary price hikes.
✅ Quality: 30+ years expertise, 100% qualification rate
✅ Production: Orders booked months ahead, continuous output
✅ Delivery: Mature supply chain, priority fulfillment for long-term partners
This “Three Guarantees” strategy reflects Haixin’s responsibility to clients and embodies its promise: From Songzi to the world—every thread, every garment is Made in China at its finest.
Product Portfolio
Category
Description
Surgical Gowns
Premium nonwoven, excellent barrier performance, comfortable for prolonged surgical procedures
Isolation Gowns
National standard compliant, superior protection, designed for healthcare and pandemic settings
Medical Face Masks
Disposable medical masks, surgical masks, KN95 respirators—high filtration, breathable fit
Disposable Medical Supplies
Surgical drapes, towels, wrapping fabrics—complete sourcing in one place
Dear Customer/Partner: Hello!
We sincerely thank you for your long-term trust and support to Hubei Haixin Protective Products Group Co., Ltd.. As an international professional company with over 30 years of industry experience and integrated manufacturing and trading, we have always been committed to providing high-quality disposable non-woven fabric solutions for the global medical and hygiene protection fields. In order to further deepen our cooperation with Japan and the Asian market and to showcase our latest achievements in non-woven fabric technology, we are honored to invite you to attend the international industry exhibition that will be held at the INTEX-OSAKA exhibition center in Osaka, Japan from March 10th (Tuesday) to March 12th (Thursday), 2026.
The main exhibits include but are not limited to:
Professional surgical gown series: Made of high-quality SMS/SMMS non-woven fabric, it offers excellent barrier properties and comfort, suitable for various surgical environments with different risk levels. Medical protective suits and isolation gowns: Designed for medical, chemical and industrial protection scenarios, providing comprehensive safety protection. Daily protective masks and medical masks: Various styles and filtration grades, meeting a wide range of needs from daily civilian use to hospital clinical applications. Disposable shoe covers/boots and caps: Covering various functions such as anti-slip and anti-static, they are widely used in hospitals, food processing plants and clean workshops in the electronics industry. Customized services: Our sales and production engineers team will be on-site to answer any questions you may have regarding product customization, packaging, and technical parameters.
International Certification:
Our products have obtained the EU CE certification, the FDA registration in the US, and the ISO9001:2000 international standard certification. They serve as the "passport" for quality to enter the global market. Stable supply: As a large-scale chemical factory with over 800 employees and a 30,000-square-meter factory area, we have strong production capabilities and supply chain guarantees, enabling us to meet the demands of large-scale orders. Global Experience: Our products are sold worldwide, including Europe, America, the Middle East, and over 50 countries and regions around the globe. We are well-versed in the needs and standards of international customers.
Exhibition Information Overview
Exhibition Name: 2026 Medical and Preventive Healthcare Exhibition in Osaka, Japan (Concurrent Medical-related Exhibitions) Event Date: March 10th, 2026 (Tuesday) - March 12th, 2026 (Thursday) Exhibition Venue: Osaka International Exhibition Center (INTEX-OSAKA), Japan Haixing Booth: Please refer to the booth map or contact us directly to obtain the specific booth number. Contact Information: If you need to schedule a negotiation time or obtain an admission ticket, please contact our foreign trade team.
We are looking forward to meeting you in Osaka and jointly drawing up a new blueprint for cooperation! This regardsSalute
Hubei Haixin Protective Products Group Co., Ltd. March 2026
Haixin Group makes a grand debut at the German Medical Exhibition
The world's leading high-tech manufacturer of medical consumables, Haixing Group, made a spectacular appearance at the MEDICA 2025 medical
exhibition in Düsseldorf, Germany. As one of the world's most influential medical device exhibitions, MEDICA attracted tens of thousands of professionals from the medical and health industries worldwide. Haiseng Group, with its advanced and innovative products, received extensive attention.
This time, we are presenting our latest surgical gowns (with the highest level of protection, ensuring compliance and peace of mind), highly breathable protective suits (comfortable to wear for long periods without any discomfort or overheating), and highly visible reflective protective suits (with bright warnings, enhancing work safety). We are showcasing these products with great significance.
![Arab Health 2025 Exhibition [ Hubei Haixin ]](http://img.hh-haixin.com/photo/ad213923083-arab_health_2025_exhibition_hubei_haixin.jpg)
Hubei Haixin at Arab Health 2025: Medical Innovations & Global Partnerships
Hubei Haixin will bring its latest fully automatic isolation gowns and surgical gowns series as well as high-visibility reflective protective clothing to the exhibition. We sincerely invite all colleagues to visit our booth for guidance. Hubei Haixing Group provides one-stop solutions for global medical device enterprises in sterile barrier systems (SBS), and is committed to the research and production of sterile barrier system products for medical hospitals and institutions.
Core Purpose
Our Advantage
STRENGTH FACTORY
With well-equipped factories and highly professional staff,
it provides a decisive guarantee for the quality of products and the speed of delivery.
30 YEAR EXPERIENCE
From the procurement of raw materials to the production, manufacturing and shipping process,
we have accumulated over 30 years of experience.
MEDICAL CERTIFICATE
Haixin Group holds the qualification certificates for medical supplies.
Mainly exports to the European Union, the United States, Canada, etc.
PROFESSIONAL SERVICE
Members of the Haixing team must have at least 8 years of experience in the medical industry.
We can offer more professional advice to serve you.
Recommended PRODUCTS
More Products
MORE information
latest news
contact us
Inquiry Me Now, Get The Price List.
