Precision Medical Silicone Accessories& OEM Solutions with ISO13485 LSR Factory

Basic Information

Model NO.

KG-293

Material Grade

Medical Grade LSR

Quality Period

One Year

Certification

ISO13485/ISO9001

Hardness Range

Customizable Shore

Biocompatibility

Full Certification

Sterilization

Eo & Autoclave Compatible

Origin

China

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, including respiratory masks, seals, catheter components, and fluid transfer tubing. We offer comprehensive OEM/ODM services, partnering with medical device brands from concept and material validation through to full-scale production.

Our Advantages

Precision Mold-Making Technology: High-accuracy tooling for complex geometries.
Competitive Price: Direct manufacturing optimization.
Professional Support: Full technology, design, and artwork assistance.
Strict Quality Management: Compliance with ISO 9001 and ISO 13485 (for medical devices).
High-Volume Precision Production: Advanced facilities capable of delivering consistent parts at scale.

Technical Specifications

Parameter Category	Specification	Standard / Value	Application Notes
Material	Medical Grade LSR	Platinum-Cured	USP Class VI, ISO 10993, FDA Compliant
Hardness	Shore A	10 A to 80 A	Customizable per function
Physical	Tensile Strength	≥ 8 MPa	Ensures durability and tear resistance
Thermal	Temp Resistance	-50°C to +200°C	Suitable for Autoclaving
Performance	Biocompatibility	Certified	Non-toxic, supports skin/fluid contact
Processing	Process Type	LSR Injection Molding	Precision for complex, flash-free parts

Certifications & Capabilities

Focusing on custom processing services for silicone products since 2007, our facility operates over 3000 square meters of production space. We specialize in LSR injection molding and HTV molding with unique advantages in one-piece overmolding technology (metal-to-silicone, plastic-to-silicone, and glass-to-silicone).

Main Product Categories

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 technical advantages?

Our main products include medical accessories, baby products (nipples), and industrial components. Our advantage lies in capturing complex technical difficulties like silicone-to-metal bonding and non-yellowing silica processes.

3. What product test reports do you provide?

We provide comprehensive environmental and safety test reports including SGS, FDA, LFGB, ROHS, and CE certifications.

4. How long is the typical delivery time?

Delivery depends on the product type and order volume, but generally, it averages around 7 days for standard production runs.

5. How do you control production quality?

We have a professional QC team managing the entire process, starting from raw material inspection through four distinct testing procedures during production to ensure final quality.

6. Do you offer customization for medical-grade parts?

Yes, we provide full OEM and ODM services, ranging from material validation and prototyping to high-volume injection molding under ISO 13485 standards.