FDA Approved Silicone Rubber Products

FDA-approved silicone rubber products are those that have been rigorously evaluated and certified by the U.S. Food and Drug Administration (FDA) as meeting the relevant safety and performance standards for use in silicone rubber products that come into direct or indirect contact with food, drugs, or the human body. These products are used in a wide range of medical, food contact and consumer product applications due to their excellent biocompatibility, temperature resistance, stability and non-toxicity.

 

Medical device parts: such as catheters, surgical instrument handles, implants (e.g., breast implants), face masks, and respirator accessories.

Oesophageal and gastrointestinal stents: used to treat strictures or to maintain open passages, these silicone products need to be biocompatible and flexible.

Baby products: e.g. silicone straws for bottles, pacifiers, which are highly safe, non-toxic, odourless and easy to clean.

Seals & Lids: used for food storage containers to ensure a tight seal, preventing leakage while maintaining food safety.
Personal Care Products:

Silicone braces and teeth whitening trays: used for orthodontic treatment or cosmetic purposes, they need to meet strict biocompatibility and hygiene standards.
 

 

Whether you have a technical drawing or just a sample, Zhongshan Melon Rubber & Plastic Products Co., Ltd. can reverse engineer your product with precision. Our expertise lies in producing a wide range of rubber shapes, from simple to highly complex, ensuring each molded rubber product meets your exact specifications. Count on us to deliver products that function flawlessly within your application.

 

About Us

 

At Zhongshan Melon Rubber & Plastic Products Co., Ltd., we are a reputable rubber factory with extensive experience. Our production base spans 20,000 square meters and includes two floors of 100,000-class dust-free workshops. With over 20 senior engineers, we are dedicated to advising our customers on the most suitable rubber, silicone, or plastic molding parts for their applications. Our engineers collaborate closely with your design team to ensure your products meet specifications.

 

Our in-house specialists can provide guidance on material selection, including NR, SBR, EPDM, SIR, CR, IIR, HNBR, FKM, and PU. We continuously integrate new technologies to meet evolving customer needs and have secured over 100 patents in the industry.

 

Our company holds ISO9001 and industry-related quality system certifications (ISO13485, SIRAICTl) and offers a one-stop solution with competitive pricing and professional service. With a comprehensive ERP system monitoring every aspect from raw material tracking to quality inspection, we prioritize customer recognition and support, offering value-added services in return.

 

Punctuality, expertise, dedication, and skilled personnel form the foundation of our successful operation. Innovation, investment in advanced equipment, and new applications drive our mutual success. We look forward to collaborating with your esteemed company for mutual growth.

 

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