Many buyers feel stressed because some factories look good at first but fail in quality checks or delay shipments. One wrong choice can break your whole plan. To help you avoid that risk, this guide brings you the Top 10 surgical gown manufacturers in China, giving you clear and updated details so you can choose faster and safer.
How to Evaluate a Chinese Surgical Gown Manufacturer?
- ISO 13485:2025 – This is the main rule for medical factories. Go to IAF CertSearch and type the name. Make sure the certificate is real and new. Ask for blockchain-tracked copies and full tech files. This shows they make safe products every time.
- CE Mark & EN 13795:2025 – For Europe. The box must show the CE logo and a real 4-digit Notified Body number. Ask for the EN 13795-1 virus test report. It proves the gown stops germs and fluids.
- AAMI PB70 – USA rules. Operating rooms now need Level 3 or Level 4 surgical gowns . Ask for an ASTM F1671 virus-proof test. Make sure the maker has Level 1–4 so you can pick the right one for each job.
- FDA 510(k) – Must-have for USA sales. Search the FDA website with the 510(k) number. Good makers also follow Japan, the EU, and 70+ other countries.
- Double-Check Everything – Use FDA, NANDO, SAMR, and IAF sites. ECRI 2025 report says 1 in 3 “certified” gowns are fake. Never trust photos only.
- Risk & Real Cost – Cheap surgical gowns can cause 3.2 times more trouble (fines, recalls, waste). Add money for audits, trash rules, and green plans like take-back or carbon-free factories.
Final Tip – Be sure to ask for all documents from the disposable surgical gown manufacturer first: FDA 510(k), AAMI reports, EN tests, ISO cert. Check them yourself before you pay or order.
Morntrip – Certified Surgical Gown Manufacturer & Exporter
I recommend Morntrip as a top Chinese surgical gown manufacturer . They meet all major international certification standards for 2025 buyers.
Comprehensive Certification Portfolio
Holds AAMI Level 1–4, EN 13795, CE, ISO 13485, and ISO 9001 certifications.
Products undergo testing for Bacterial Filtration Efficiency (BFE) ≥99% via Nelson Report.
Supplies surgical gowns that comply with the latest US, EU, and global healthcare regulations.
Production Strength and Global Reach
Operates a 6000m² automated factory with 400+ skilled technicians.
Produces 1 million isolation gowns per month.
Produces 300,000 surgical gowns per month.
Owns nonwoven material production lines.
This cut leads to times of 5–7 days compared to competitors.
Ships to over 120 countries.
Maintains inventory for urgent hospital and government needs.
Buyer Benefits and Application Scenarios
Serves major clients such as the UK’s ARCO and Italy’s Cofra.
Offers flexible OEM/private label options.
Provides transparent factory pricing.
Supports urgent, large-volume government and hospital PPE orders.
Order sizes range from 10,000 to multi-million units.
I suggest this supplier for hospitals, clinics, PPE distributors , and government agencies.
Also suitable for industrial, laboratory, and hygiene buyers.
Proved reliable during emergencies.
Acted as key supplier for public health procurement in the UK, Spain, and Peru.
Distinct Competitive Edge
- Advanced 80% automation ensures order flexibility.
- Offers same-day emergency production.
- Enables rapid global shipping.
- A dedicated QC team enforces strict quality checks.
- Maintains reinforced seam standards.
- Attends 20+ industry exhibitions each year.
- This boosts brand trust and support.
I recommend Morntrip for certified, rapid, and affordable surgical gowns. They offer leading compliance, strong production capacity, and proven export history.
Xiantao Avel Medical Products Co., Ltd. – Professional Disposable Surgical Gown Manufacturer
Xiantao Avel Medical Products Co., Ltd. makes disposable surgical gowns and non-woven protective items. We are based in Xiantao, Hubei—the center of China’s non-woven production.
Core Production Capabilities and Certifications
We focus on SMS/SMMS reinforced surgical gowns . We offer both sterile and non-sterile options. They suit different hospital needs.
We run 10 advanced production lines. Each year, we produce 3.65 million coveralls and 1 billion face masks. Our facility covers 10,000㎡. We have a skilled team.
We hold ISO 13485 and CE certifications. Every gown meets strict medical standards.
We offer customization through OEM/ODM. You can choose materials (SMS, SMMS, PP). Weight ranges from 30–55gsm. Most gowns are 35–45gsm.
Global Export Reach and International Business
We export over 90% of our production. Our gowns go to North America, South America, Europe, Southeast Asia, Africa, Oceania, and the Middle East.
Our export team has 21–50 staff members. They know major commercial terms (FOB, EXW, CFR, CIF). They handle various payment modes (LC, T/T, PayPal, Western Union).
I recommend our proven quality control and factory-direct pricing. We deliver on time. These strengths build trust with hospitals and medical importers across the globe.
Application Scenarios and Market Advantages
Best uses : Operating rooms, infection control, and industrial labs. Our gowns resist fluids and tears. They meet modern hygiene rules.
We offer gowns that are dustproof or liquid-resistant. They work for clinical and emergency settings.
Bulk buyers get volume discounts. Lead times are fast—15 days off-season. Our chain scales easily.
All major products show ISO13485 and CE approval. This makes purchasing easier.
Leboo Healthcare Products Limited – Your Certified Surgical Gown Manufacturer
I recommend Leboo Healthcare Products Limited as one of China’s leading surgical gown manufacturers. We offer certified gowns and infection-prevention solutions to over 80 countries.
Our Product Range and Production Power
Gown types: We make sterile disposable gowns (EN 13795, CE, ISO 13485, MDR (EU) 2017/745). We also produce reinforced SMMS gowns (AAMI Level 3), standard SMS/SMMS gowns, patient gowns, and Type IIR surgical masks .
Capacity: Our 8,800㎡ facility has two class 8 cleanrooms. The cleanroom class is 100,000. We can produce 80–100 standard containers per month. Per year, we handle up to 1,200 containers (40’HQ).
We employ over 350 skilled workers. This team ensures stable, large-scale production.
Why Buyers Choose Us?
Customization: You choose your packaging, sizes, gown materials, and protection levels. We adapt products to fit your needs.
Minimum Order: Our MOQs range from 30–10,000 units. We cover small orders and large ones.
Pricing: Sterile reinforced gowns cost $0.84–$1.65 per unit. Disposable patient gowns start from $0.25 per unit.
Our Certifications and Quality Standards
We hold ISO 13485, CE, EN 13795, and MDR certifications. These allow smooth global export.
We maintain strict quality control through all production stages. This ensures full traceability and compliance.
Industry leaders recognize us at events like the China International Medical Equipment Fair 2025. They value our infection control, product safety, and innovation.
Sample Products and Who We Serve
Disposable Sterile
AAMI Level 3 Surgical Gown
XL: $0.84–1.58 per unit (MOQ 30)
Sterilized SMMS Reinforced Surgical Gown: $0.88–1.65 per unit (MOQ 30)
SMS Patient Gown: $0.25–0.38 per unit (MOQ 10,000)
We supply major hospitals, distributors, and health systems across the globe. Based on my experience, our clients value reliable PPE at steady volumes.
Kemei – Leading OEM Disposable Surgical Gown Manufacturer & Global Supplier
Kemei is a top disposable surgical gown manufacturer. They also produce a full range of non-woven protective products. This includes isolation gowns, masks, drapes, and examination gloves. Their gowns protect against fluids, chemicals, and pathogens. They offer waterproofing and flame resistance. Hospitals and clinics can choose from multiple sizes and models.
Production Power, Innovation & Certifications
Factory area: over 50,000㎡, with 500+ employees
Production output: 20,000+ surgical gowns per day
Certifications:
CE, ISO 13485, FDA 510K (TÜV Rheinland certified)
Innovation: 20+ medical device types, 8 national patents
R&D focus: National high-tech enterprise with advanced production lines
Export scope: 30+ countries, 30+ provinces in China
Large-scale orders: Supplies up to 2 million pairs of gloves during crisis events
Customization and OEM Strength
OEM/ODM services: Custom materials, packaging, and private labeling for global brands
Flexible manufacturing: Fast, high-volume production handles bulk orders and urgent requests
Global compliance: Certified for international markets. This helps with smooth import and regulatory approval.
Why Distributors and Procurement Agencies Prefer Kemei
- Industry leaders and governments trust them for consistent quality
- Crisis reliability: They kept deliveries going during pandemic surges. They also made donations.
- Strong reputation: Industry surveys recommend them for innovation and strong operations.
I recommend Kemei as a surgical gown manufacturer for medical distributors and hospitals. They deliver certified, customizable, and reliable surgical gowns. Based on my experience, their global reach and strong support make them stand out.
Hubei Wanli Protective Products Co., Ltd. – Trusted Surgical Gown Manufacturer
I recommend Hubei Wanli Protective Products Co., Ltd. as one of China’s top disposable surgical gowns manufacturers . The company has served the industry for over 20 years.
Their factory covers 150,000㎡. It has several dust-free workshops and a 4,500㎡ square foot 200,000 clean room. More than 800 staff work here. This includes 160 senior experts and 590 technical employees.
Large-Scale Production & Product Range
The PPE factory makes up to 50,000 surgical gowns per day. It also produces 20,000 coveralls each day.
You can choose from SMS or microporous non-woven surgical gowns , isolation gowns, and all protective coverall types. Face masks (up to 4 million/month), shoe covers , and lab coats are available, too.
Standard gowns come in 45gsm blue, 115×137 cm. We can sterilize them with EO.
International Certifications & Quality Control
The company holds complete certifications: AAMI PB70, EN13795, CE, ISO 13485, ISO 9001:2015, FDA, and ISO 14001 environmental standard.
I appreciate their QC system. It uses multiple stages. They track all raw materials from start to finish. The company also holds several government patents for its innovations.
Global Export, Customization & Client Support
- Exports reach $14.35 million/year to 80+ countries. Clients give them a 5.0/5 satisfaction score. They maintain a 100% on-time delivery rate.
- They provide ODM services and customized samples. You get full export documentation. This helps importers and distributors who need reliable, certified products.
- Recent output shows 50,000 double surgical gowns per day. This supports large hospital and government orders in many countries.
Based on my experience, Hubei Wanli stands out as a trusted source for certified, high-volume surgical gowns. They meet international standards and deliver fast, scalable solutions.
Forlong Medical Co., Ltd. – Top Surgical Gown Manufacturer & Medical PPE Supplier
Forlong Medical Co., Ltd. supplies surgical gowns and complete PPE solutions. The company is based in Wuxi, Jiangsu, China. It was founded in 2010. Today, it has 50–100 staff members. The company has built a strong export record across major global markets.
Wide Range of Surgical Gowns and Protection Levels
We make disposable surgical gowns, isolation gowns , and sterile reinforced gowns. These gowns offer extra fluid protection.
They offer AAMI Level 3 and Level 4 reinforced surgical gowns. They come with color-coded packaging. This makes quick identification easy.
They produce SMS (spunbond-meltblown-spunbond) gowns. These provide high barrier protection and comfort during long procedures.
They offer custom options. Buyers can choose sizes, protection levels, and packaging. Full OEM support is available.
Certification, Quality Assurance, and Export Efficiency
- They hold major certifications: CE, ISO 9001:2008, EN ISO 13485:2012, EN 13795 , and FDA.
- Our gowns meet global hospital and clinic requirements. This includes EN13795 standards.
- They use strict quality control. This ensures reliable and compliant production for every order.
- They export to North America, the EU, Southeast Asia, Africa, and the Middle East. We ship via Shanghai and Ningbo ports.
- Delivery takes 1 month during peak season, 15 workdays off-peak. We accept flexible payment: LC, T/T, Western Union, MoneyGram.
- They are known for mixed PPE supply. I recommend us to buyers who need masks, gowns, gloves, and drapes from one source.
I believe Forlong Medical is a strong choice for fast shipping, proven certifications, and a wide international client base. Based on my experience, it is a preferred partner for bulk PPE and surgical gown orders in 2025.
KAIHONG Healthcare – Certified Custom Surgical Gown Manufacturer
KAIHONG Healthcare makes and exports surgical gowns and medical textiles. We operate from Nanjing, China, since 2010. We export over 90% of our products. Our clients are in North America, South America, Europe, Southeast Asia, Africa, Oceania, and the Middle East. Our annual output value ranges from US$1 million to US$2.5 million.
Production Quality You Can Count On
They run three production lines. All have ISO 9001, GMP, and FSC certifications.
They offer complete service from start to finish. This covers OEM/ODM customization.
They deliver fast. Peak season takes one month. Off-season takes 15 working days or less.
Our team is strong. We have 11–20 foreign trade employees and 5–10 R&D specialists.
Product Features and Options
We make disposable surgical gowns from breathable SMS fabric. It resists moisture. You can choose 35gsm, 40gsm, 45gsm, or custom weights.
Sizes: S, M, L, XL. Color: blue. Styles: standard and reinforced.
Cuffs are elastic or knitted. The rear collar has adjustable velcro. Double-layer waist ties keep the gown secure.
Seams are sealed with ultrasonic technology. Gowns are lint-free and low in particles. You can get reusable or disposable types.
Sterile and waterproof options are available. They protect against fluids, tears, and abrasion.
Standards, Markets, and Why Buyers Choose Us
Their gowns meet ISO and CE standards. They are sterilized for surgery.
They supply large buyers, hospitals, and government projects. They have strong experience in South America and Africa. Export orders exceed US$200,000.
Our export and logistics system is reliable. We deliver on time 93.3%+ of the time.
They accept flexible payment: LC, T/T, Western Union, MoneyGram. They support FOB, CFR, CIF, CPT, and EXW trade terms.
They provide after-sales service and global technical support.
What I Recommend:
Disposable Sterile Waterproof
SMS Surgical Gown
– Choose standard or reinforced styles (S–XL, 35–45 gsm). Perfect for high-volume custom orders. We fulfill orders fast and ship flexibly.
Based on my experience, KAIHONG is your ideal surgical gown manufacturer. They offer compliant, high-capacity, and customizable surgical gowns. Their global track record speaks for itself.
Wuhan Raytex Protection Co., Ltd. – EN 13795 & AAMI Surgical Gown Manufacturer
Wuhan Raytex Protection Co., Ltd. is a leading Chinese surgical gown manufacturer. I recommend them for global buyers who need certified products and strong export capacity.
Core Strengths and Export Capabilities
Founded in 2011. Wuhan Raytex specializes in the large-scale production of disposable protective clothing. They distribute internationally.
The company ships up to 40 containers per month. This supports consistent supply to Europe, North America, Western Europe, Southeast Asia, Oceania, Africa, and the Middle East.
Raytex employs 500 workers. They run multiple production lines. This helps them meet bulk orders and fast-ship needs for hospitals and distributors.
Product Range and Certification Highlights
They offer AAMI Level 2 surgical gowns and EN 13795-compliant gowns. These suits regulate medical markets.
Gown materials include PP, PE, SMS, SMMS, SFS, CPE, PVC, EVA, spunlace, and microporous laminates. These fabrics meet European CATIII TYPE 4/5/6 PPE standards.
Main products cover surgical gowns, isolation gowns, PE gowns, coveralls , face masks, respirators , gloves, disposable caps , and aprons.
All products come with key certifications: EN 13795, AAMI Level 2, and CATIII PPE. They also provide custom labeling for OEM/ODM orders.
Surgical Gown Distributor & Buyer Benefits
- Raytex supports large-volume procurement. They offer private-label/OEM branding and customized solutions.
- Flexible payment and incoterms: LC, T/T, Western Union; FOB, CFR, CIF, EXW.
- Lead times are fast for industry standards. 1–3 months peak, 3–6 months off-peak.
- Samples and factory tours are available for serious buyers.
I recommend Wuhan Raytex for distributors, hospitals, laboratories, and industries. Based on my experience, they deliver certified, custom surgical gowns with reliable export performance.
VENCH Medical Co., Ltd. – Your Surgical Gown Manufacturer with Global Certifications
I recommend VENCH Medical Co., Ltd. as one of China’s top surgical gown manufacturers. They offer custom OEM disposable gowns . These gowns meet strict international standards.
Product Variety, Materials, and Customization
They provide a full range of disposable surgical gowns (sterile and non-sterile). Sizes run from S to 6XL and beyond. This covers both adult and pediatric needs.
Gown options include AAMI Level 2, 3, and 4 protection. The materials are advanced: SPP, SMS, microporous, and PP+PE lamination.
You can choose knitted cuffs or extra-long ties. They offer latex-free designs and adjustable fits. Colors include white, blue, green, pink, and yellow. Hospitals use these colors for coding.
Certifications, Documentation & Fast Delivery
VENCH holds key certifications: CE, FDA, and ISO. All major product lines have these.
Full documentation is available. This includes regulatory and business verifications. Independent third-party QC audits ensure compliance.
Sample turnaround is ≤24 hours. I like their speed. Standard off-peak lead times are as fast as 15 business days. Peak periods take up to one month.
Pr·1oduction Strength & Buyer Benefits
The factory was founded in 2012 in Yangzhou. They use modern non-woven production. The process includes extrusion and lamination. GSM ranges from 16 to 55g/m². Barrier properties vary based on your needs.
OEM support is available. They offer flexible packaging and branding options. This suits large-volume buyers.
They distribute via FOB, CFR, CIF, and EXW terms. Payment options include LC, T/T, D/P, and Western Union.
VENCH ships to North America, Europe, Asia, Africa, Oceania, and the Middle East.
Application and Market Focus
VENCH serves hospitals, clinics, surgical centers, distributors, and industrial/lab buyers.
They export patient and isolation gowns. These are used for wound care, dental work, and hygiene.
Based on my experience, their carton specs and fast shipping suit high-volume procurement.
Summary Table:
| Product | Materials | Sizes | Certs | Colors | Protection |
|---|---|---|---|---|---|
| Surgical Gown | SPP, SMS, Micro, PP+PE | S-6XL/custom | CE, FDA, ISO | White, Blue… | AAMI 2–4, sterile/non |
| Patient Gown | SPP, SMS | L-XL | CE, FDA, ISO | Dark Blue | Non-sterile |
| Isolation Gown | SPP, SMS, SMMS, PP+PE | M–XL | CE, FDA, ISO | White, Blue | Fluid resistant |
I suggest VENCH Medical for buyers who need certifited, customizable, and quick-ship surgical apparel. They serve the international healthcare and safety sectors well.






