Medical-Grade Silicone Rubber Gasket | Longrun RubberMedical-Grade Silicone Rubber Gasket
Product Summary
Our medical-grade silicone rubber gasket is produced from high-purity silicone meeting USP Class VI or ISO 10993 biocompatibility standards. Designed for medical devices, pharmaceutical processing, and laboratory equipment requiring non-toxic, sterilizable seals. Customizable in hardness, dimensions, color, and physical properties.
Key Selling Points
- Biocompatible Material: Medical-grade silicone complies with USP Class VI and ISO 10993 for safety in contact with body fluids or tissues.
- Sterilization Compatible: Withstands autoclave, ethylene oxide (EtO), and gamma radiation sterilization methods.
- Precision Manufacturing: Process capability Cpk > 1.33 and defect rate < 150 ppm ensure consistent quality for critical applications.
- Customizable Properties: Hardness, dimensions, color, and physical properties tailored to your application (source: custom-made parameters).
- Certified Quality: ISO 9001:2015 (BSI) and IATF 16949:2016 (BSI) certified.
Technical Specifications
| Property | Value |
|---|
| Material | Medical Grade Silicone Rubber (VMQ) |
| Tensile Strength | ≥ 8 MPa (source: case study) |
| Elongation at Break | ≥ 450% (source: case study) |
| Tear Strength | ≥ 35 KN/m (source: case study) |
| Temperature Range | -60°C to +200°C |
| Hardness | Customizable (20-80 Shore A typical) |
| Biocompatibility | USP Class VI / ISO 10993 (typical) |
Models and Options
Available as Medical-grade gaskets. Other variants include Oil-resistant, Chemical-resistant, High-temperature, Low-temperature, Food-grade, and High-pressure flange gaskets.
Materials and Structure
Custom-made from Medical Grade Silicone Rubber. Material formulation optimized for biocompatibility and sterilization resistance.
Applications
Medical devices (syringes, catheters, diagnostic equipment), Pharmaceutical production (seals for reactors, storage vessels), Laboratory instruments, and any application requiring sterile, non-toxic sealing.
Customization
Custom-made: hardness, dimensions, color, physical properties. MOQ varies; contact us for details.
FAQ
- Is this gasket suitable for implantable devices? Please consult with our technical team regarding specific biocompatibility requirements.
- Can it be sterilized by autoclave? Yes, silicone can withstand repeated autoclave cycles.
- What is the MOQ? MOQ varies per product; please inquire.
- Do you offer third-party inspection? Yes, available.
- What certifications do you hold? ISO 9001:2015 and IATF 16949:2016.
- Can you provide material certificates? Yes, upon request.
- What is the export ratio? 80% to global markets.
- How to contact sales? Email tommyliu@longrunrubber.com or call +86 13006697998.
Company: Longrun Rubber Products (Huizhou) Co., Ltd.
Contact: Tommy Liu / Victor Hang
Email: tommyliu@longrunrubber.com / hang@longrunrubber.com
Phone/WhatsApp: +86 13006697998
Address: 7# factory building, No. 27 Songbailing Avenue, The start-up area of China-South Korea Huizhou Industrial Park, Zhongkai High-tech Zone, Huizhou, Guangdong, 516302, China.
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Additional Image: inspection-room.jpg (Alt: Inspection room at Longrun Rubber ensuring quality)
