OEM/ODM Silicone Custom Products Medical Grade Molded Silicone Rubber Parts

• Material: Silicone, LSR, Rubber
• Application: Medical, Health and Food Safety
• Certification: UPS Class VI, ISO 10993, FDA, CE, ISO
• Function: Air Seal, Water Seal, Oil Seal;Corrosion Resistanc
• Characteristic: Biocompatibility
• Molding Method: Injection Molding
• Model NO.: 240524
• Hardness: 20-80shore
• Transport Package: by Sea, by Air, by Train, Customized
• Specification: Standard, Nonstandard, Customized
• Trademark: OEM/Custom
• Origin: China
• HS Code: 4016101000
• Production Capacity: 50000000

Product Description

At the forefront of medical technology, we specialize in providing high-end manufacturing services for medical-grade silicone components, dedicated to meeting the highest demands for material safety, performance and innovation in the medical device, biotechnology and healthcare industries. Relying on advanced manufacturing processes and strict quality management systems, we ensure that each silicone part is not only a precision component, but also an important safeguard for the safety and health of patients.

Product Description

Core Advantages

Top medical-grade materials: We use strictly certified medical-grade silicone raw materials, which comply with ISO 10993 biocompatibility standards and USP Class VI requirements, are non-toxic, non-allergenic, and suitable for long-term implantation or short-term contact applications, ensuring patient safety.

Precision Manufacturing Process: Adopting advanced liquid silicone rubber (LSR) injection molding technology, combined with high-precision molds and automated production lines, we produce silicone parts with microscopic features, complex structures and strict dimensional tolerances to meet the stringent demands of medical devices for precision.

Comprehensive customization service: From conceptual design, prototype development to mass production, we provide one-stop customization solutions. A team of professional engineers works closely with customers to ensure the feasibility and cost-effectiveness of the design, accelerating the process from R&D to market.

Strict quality control: Following ISO 13485 medical device quality management system, we implement a comprehensive quality control process, including raw material inspection, online monitoring, finished product testing and traceability system, to ensure that each product meets the highest quality standards in the medical industry.

Wide range of applications: Our medical-grade silicone parts are widely used in urinary catheters, surgical instruments, infusion lines, respiratory masks, seals, medical gaskets, implant coats, and other types of medical devices, providing a solid foundation for medical innovation.


 

Detailed Photos

Project Advantage:

• Perfect surfaces without the need for trimming


• Mold join burr must be less than 0.05 mm


• Minimized evaporation and tight against high-pump pressure


• Cleanroom manufactured for high cleanliness standards


• Compliant with FDA 21 CFR and UPS Class VI regulations

Technical Specification
Material	NBR, NR, EPDM,FVMQ,HNBR,LSR,CR,Silicon, PU,SBR,IIR
Size/Color	Customized
Hardness	20-90 Shore A
Processing Way	Compression, injection, injection transfer, extrusion, silicone liquid injection
Certificates	SGS, RoHS. Reach
Packing	PE plastic bags then to the carton / as customized
Payment	T/T, Paypal, Western Union,Payoneer
MOQ	5000 PCS
Shipping Method	SEA,AIR,DHL,UPS,FEDEX,TNT, etc.
Delivery Time	7 days for prototype tooling & samples, 14 days for production mold, 14-28 days for MOQ

Company Profile &Certification

Zhongshan Melon Rubber & Plastic offers ISO-certified medical grade silicone parts production in a 10000 class cleanroom. Specializing in custom silicone molding and LSR injection molding services.

About Us

 

Zhongshan Melon Rubber & Plastic Products Co., Ltd. is a recognized experienced rubber factory with a production base covering an area of 20,000 square meters. Our two floors of 100,000-class dust-free workshops house more than 20 senior engineers.

 

Our Services

 

We specialize in advising customers on the most suitable rubber, silicone, or plastic molding parts for their applications. Our engineers work closely with design engineers to ensure products meet specifications. We offer material selection expertise in NR, SBR, EPDM, SIR, CR, IIR, HNBR, FKM, and PU.

 

Quality Assurance

 

We have obtained over 100 patents in the industry and hold ISO9001 and industry-related quality system certifications (ISO13485, SIRAICTl). Our one-stop solution, competitive pricing, and professional service are supported by a thorough ERP system monitoring every process from raw material tracking to quality inspection.

 

Our Commitment

 

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

Reasons for choosing us

By choosing our medical grade silicone parts manufacturing service, you get not only high quality products, but also a partner who is committed to the progress of medical and health care. We promise to help you innovate your medical products with the most advanced technology, the strictest standards, and the most attentive service, and jointly guard the health and well-being of mankind.

Contact us now to start the journey of customizing medical-grade silicone parts, and let every cooperation be a powerful push forward for medical technology.

 

FAQ

Q:Are you a trader or a manufacturer?

A:We are a trading and manufacturing company with specialized manufacturing factories and trading departments.

Q: How can I get some samples? 

A:Please contact us. We are honored to offer you free samples.  It will cost some sample charge for custom

designs,but it is refundable when order is up to certain quantity. 

Q: What is your delivery time?

A: 7 days for prototype tooling & samples, 14 days for production mold, 14-28 days for MOQ.

Q: Why choose us? 

A: We have professional team with rich experiences and high precision equipment which can guarantee the

product quality, through our scientific management and strict cost control we can offer you the best competitive !

Welcome to inquire, let's get started!