Precision Medical Silicone Accessories& OEM Solutions with ISO13485 LSR Factory

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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

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.

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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.

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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

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.

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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.