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Welcome to our guide on the top 10 CE-certified disposable surgical gown factories in China for 2024. As a healthcare professional or buyer, finding reliable surgical gown factories is crucial for maintaining safety and quality standards. Our carefully researched list highlights the best manufacturers in the industry, all of whom meet strict CE certification requirements.
We’ve done hard work verifying these factories, through the databases like FDA, TÜV Rheinland, and TÜV SÜD, so you can trust the information provided. By reading this guide, you’ll gain valuable insights into where to source high-quality disposable surgical gowns, streamlining your procurement process and ensuring you invest in reliable products.
CE Certification: Sterile vs. Non-Sterile Surgical Gowns
CE registration processing differs significantly for disposable surgical gown factories based on product sterility. Sterile surgical gowns, classified as Class I (sterile) medical devices, require rigorous testing, extensive documentation, and frequent audits. In contrast, non-sterile gowns fall under Class I (non-sterile), facing less intensive evaluation. Understanding these distinctions is crucial for factories to navigate the CE registration process effectively.
Classification
- Non-sterile surgical gowns are typically classified as Class I medical devices.
- Sterile surgical gowns are classified as Class I sterile medical devices.
Conformity Assessment
Non-Sterile Surgical Gowns (Class I): These can often be self-declared by the manufacturer without the involvement of a notified body. The manufacturer can conduct the conformity assessment independently and apply the CE marking.
Sterile Surgical Gowns (Class I Sterile): These require the involvement of a notified body, such as SGS, TÜV Rheinland, and TÜV SÜD, for the aspects related to sterility. The notified body must assess and certify the sterilization process.
Documentation and Requirements:
Non-Sterile Gowns: Disposable Surgical Gown Factories need to prepare technical documentation and a Declaration of Conformity, but the process is generally less complex.
Sterile Gowns: In addition to the requirements for non-sterile gowns, manufacturers must provide detailed information about the sterilization method, validation processes, sterility assurance level (SAL), and packaging that maintains sterility.
Regulatory Oversight
Sterile gowns are subject to more rigorous regulatory oversight than non-sterile gowns, due to the critical nature of maintaining sterility for surgical procedures.
Labeling
Sterile gowns must be clearly labeled as sterile and include information about the sterilization method used. This ensures that medical professionals can trust the gown’s sterility and know the exact process it underwent.
In summary, while non-sterile surgical gowns can often go through a simpler CE marking process with self-declaration, sterile surgical gowns require a more comprehensive approach involving a notified body, additional documentation, and stricter quality control measures to ensure compliance with CE marking requirements. This difference reflects the higher risk associated with sterile products used in surgical settings.
Top 10 Sterile Disposable Surgical Gown Factories with CE certification
Morntrip - Comprehensive Disposable Medical Gown Factory
Wuhan Morntrip Trading Co., Ltd. is a prominent supplier and manufacturer of PPE based in Wuhan, Hubei, China. Established in 2015, the company specializes in a wide range of disposable non-woven products, including face masks, surgical gowns, and coveralls, and is known for its commitment to quality, with certifications such as CE and ISO9001:2008. Morntrip operates a large production facility and offers customized solutions to meet diverse client needs, serving customers in over 120 countries.
- Location: Pengchang Road, Xiantao, 433018 Hubei, China
- Certificates: CE, ISO 13485
- CE Notified Body: TÜV Rheinland
- Products: Surgical Masks, Surgical Gowns, Coveralls, Disposable Caps, Sleeve Covers, Shoe Covers…
Tongda - Expert Manufacturer of Disposable Non-woven Goods
Xiantao Tongda Non-woven Products Co., Ltd. is a professional manufacturer of disposable non-woven products located in Pengchang town, Xiantao, China’s largest non-woven city. Established with over 10 years of experience, the company specializes in producing a wide range of products including face masks, protective clothing, isolation gowns, and other medical and sanitary items, with a production area exceeding 30,000 square meters and annual sales of 500 million RMB. Tongda adheres to strict quality standards, holding certifications such as ISO13485 and European CE, and exports its products to markets in Europe, North America, and other regions worldwide.
- Location: Pengchang Road, Xiantao, 433018 Hubei, China
- Certificates: CE, ISO 13485
- CE Notified Body: TÜV Rheinland
- Products: Face Masks, Surgical Gowns, Coveralls and Caps
Weigao - Innovator in Disposable Medical Devices
Established in 2002, Weihai Weigao Medical Materials Co., Ltd. is a leader in disposable surgical gowns. Based in Weihai, Shandong, China, the company holds 66 patents and certifications including CE, ISO 13485, and FDA 510K. They offer a wide range of medical products, ensuring quality and safety with TÜV SÜD certification.
- Location: Weihai, Shandong, China
- Certificates: CE, ISO 13485, FDA 510K
- CE Notified Body: TÜV SÜD
- Products: Surgical Gowns, Sterile Surgical Kits, Medical Nursing Pads, Disposable Diapers
Leboo - Specialist in Disposable Medical Equipment
Founded in 2006, Leboo Healthcare Products Limited is based in Beijing, China. The company specializes in surgical gowns, drapes, and masks, with certifications including CE, ISO 9001, and ISO 13485. Accredited by TÜV Rheinland, Leboo is known for its high-quality medical disposables.
- Location: Beijing, China
- Certificates: CE, ISO 9001, ISO 13485
- CE Notified Body: TÜV Rheinland
- Products: Surgical Gowns, Drapes, Isolation Gowns, Face Masks
Medplus - Premier Provider of Surgical and Infection Control Solutions
Located in Yangzhou, Jiangsu, China, Jiangsu Medplus Non-woven Manufacturer Co., Ltd. was founded in 2009. They specialize in disposable surgical gowns and infection control products, with certifications including CE, ISO 13485, and FDA 510K.
- Location: Yangzhou, Jiangsu, China
- Certificates: CE, ISO 13485, FDA 510K
- CE Notified Body: TÜV Rheinland
- Products: Surgical Gowns, Face Masks, Shoe Covers, Surgical Drapes
Foshan Nanhai Plus - Expert in Disposable Medical Products
Established in 2007, Foshan Nanhai Plus Medical Co., Ltd. is located in Foshan, Guangdong, China. The company offers a wide range of medical supplies, including surgical gowns and drapes, with certifications like CE, ISO 13485, and FDA 510K.
- Location: Foshan, Guangdong, China
- Certificates: CE, ISO 13485, FDA 510K
- CE Notified Body: TÜV Rheinland
- Products: Surgical Gowns, Drapes, Procedure Packs, Face Masks
Dongguan Shin Yi - AAMI Level 3 Surgical Gowns Factory
Since 1988, Dongguan Shin Yi Healthcare Products Factory in Dongguan, Guangdong, China, has specialized in disposable surgical products. They hold CE, ISO 13485, and FDA 510K certifications, ensuring top quality.
- Location: Dongguan, Guangdong, China
- Certificates: CE, ISO 13485, FDA 510K
- CE Notified Body: TÜV Rheinland
- Products: Surgical Gowns, Drapes, Procedure Packs
Kemei - Discover the Excellence of Disposable Surgical Gown Factories
Founded in Nanchang, Jiangxi, China, Kemei Medical Apparatus & Instruments Group Co., Ltd. offers superior-quality surgical gowns and masks. Certified by CE, ISO 13485, and FDA 510K.
- Location: Nanchang, Jiangxi, China
- Certificates: CE, ISO 13485, FDA 510K
- CE Notified Body: TÜV Rheinland
- Products: Surgical Gowns, Masks, Examination Gloves, Surgical Drapes
Zhongtai - Leading Manufacturer of Disposable Medical Products
Established in 2003, Xiantao Zhongtai Protective Products Co., Ltd. is located in Xiantao City, Hubei, China. The company specializes in surgical gowns and other nonwoven products, holding CE and ISO 13485 certifications.
- Location: Xiantao, Hubei, China
- Certificates: CE, ISO 13485
- CE Notified Body: TÜV Rheinland
- Products: Surgical Gowns, Face Masks, Caps, Surgical Kits
Xingrong - Premier Provider of Disposable Healthcare Protection
Founded in 2003, Xiantao Xingrong Protective Products Co., Ltd. is based in Xiantao, Hubei, China. The company specializes in face masks and surgical gowns, certified by CE and ISO 13485.
- Location: Xiantao, Hubei, China
- Certificates: CE, ISO 13485
- CE Notified Body: TÜV Rheinland
- Products: Surgical Gowns, Face Masks, Caps, Shoe Covers
These top 10 CE-certified disposable surgical gown factories in China represent the pinnacle of quality and reliability in the medical supply industry. Each company has demonstrated a commitment to excellence through rigorous certifications, innovative product lines, and adherence to international standards. By choosing from these manufacturers, healthcare providers and distributors can ensure they’re sourcing high-quality surgical gowns that meet the strictest safety and performance requirements. As the healthcare landscape continues to evolve, these factories stand ready to meet the growing demand for superior protective equipment.
Reach out to Morntrip for personalized assistance if you need to source disposable surgical gowns in China. Morntrip has more than 20 years of experience in surgical gown manufacturing, we know how to cut down your purchasing costs and find reliable competitive supply sources for your requirements. Contact info@morntrip.com to guide you through the process and help you make an informed decision.
