Precision Medical Silicone Accessories& OEM Solutions with ISO13485 LSR Factory

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Product Description

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Basic Information

Model NO.
KG-293
Sterilization
EO & Autoclave Compatible
Quality Guarantee
One Year
Material Grade
Medical Grade LSR
Certification
ISO13485 / ISO9001
Hardness Range
Customizable Shore A
Surface Finish
Medical Smooth
Biocompatibility
Full Certification
Origin
China
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Product Description

Medical Silicone Accessories
LSR Factory Solutions
Customized Medical Silicone Components: We are a specialized manufacturer of precision Medical Silicone Rubber Products and Custom Medical Silicone Components, utilizing advanced Liquid Silicone Rubber (LSR) manufacturing processes under a strict ISO 13485 certified quality management system. Our expertise lies in producing high-purity, biocompatible, and reliable liquid silicone products for critical healthcare applications.
We offer comprehensive OEM/ODM services, partnering with medical device brands from concept and material validation through to full-scale production, ensuring each custom silicone product meets the most demanding performance and regulatory standards. Our commitment is to deliver exceptional quality, consistency, and safety for all your medical silicone component needs.
Silicone Component 1
Silicone Component 2
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Our Advantages

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Precision Mold-Making: Advanced technology for complex and flash-free parts.
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Competitive Price: Direct factory manufacturer ensuring cost-efficiency.
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Professional Support: Expert technology, design, and artwork assistance.
Strict Quality Management: ISO 9001 and ISO 13485 (Medical Devices) certified.
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High-Volume Production: Large scale manufacturing for consistent quality.
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Technical Specifications

Category Property Standard / Value Application Details
Material Grade Medical Grade LSR (Platinum-Cured) USP Class VI, ISO 10993, FDA Compliant
Physical Hardness (Shore A) 10 A to 80 A Customizable based on function
Physical Tensile Strength ≥ 8 MPa Durability in dynamic applications
Performance Temp Resistance -50°C to +200°C Suitable for Autoclave & Cryogenic
Performance Biocompatibility Certified Non-toxic, skin/fluid contact safe
Surface Finish Medical Smooth / Textured Minimizes bacterial adhesion
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Certifications & Capabilities

Certification 1
Certification 2
Certification 3
Established in 2007, we are a high-tech company focused on custom processing services for silicone products. With a modern factory of more than 3000 square meters, we utilize advanced LSR injection molding and HTV molding technologies. We specialize in overmolding silicone with metal, plastic, and glass for diverse medical and industrial applications.
Factory View 1
Factory View 2

Frequently Asked Questions

1. Are you a production plant or a trading company?
We are a professional manufacturer of liquid and solid silicone products, specializing in medical supplies, kitchenware, and industrial parts.
2. What are your main products and industry advantages?
Our main products include medical LSR components, baby products, and kitchen utensils. Our technical staff has over 20 years of experience, allowing us to solve complex bonding issues between silicone and metal/plastics.
3. What is your monthly production capacity?
We have 7 sets of liquid silicone injection machines and 15 solid molding machines. Our current monthly production capacity is approximately 50 tons.
4. Which test reports do your products carry?
Our products comply with SGS, FDA, LFGB, ROHS, and CE environmental standards to ensure safety and quality for medical and food-grade use.
5. How do you control the production quality?
We have a professional QC team that monitors everything from raw materials to final packaging through 4 distinct testing procedures to ensure zero-defect quality.
6. What is the typical lead time for delivery?
Delivery time depends on the specific product and order volume, but in general, the standard delivery time is approximately 7 days.

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