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Home > products > Medical Grade Silicone Rubber > FDA 21 CFR 1772600 Medical Garde Material Density 111 Gcm3 Suitable for Food Contact and Medical Equipment Manufacturing

FDA 21 CFR 1772600 Medical Garde Material Density 111 Gcm3 Suitable for Food Contact and Medical Equipment Manufacturing

Product Details

Place of Origin: Guangzhou, China

Brand Name: RUIHE

Certification: ISO13485, RoHS, REACH, FDA

Model Number: 6250‑50YHAB

Payment & Shipping Terms

Minimum Order Quantity: 20KG

Packaging Details: 20kg A+B per drum

Delivery Time: 7‑15 Working Days

Payment Terms: T/T

Supply Ability: 10000 Kilogram / Month

Get Best Price
Highlight:

FDA 21 CFR 1772600 Medical Grade Silicone Rubber

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Density 111Gcm3 Medical Grade Silicone Rubber

Hardness:
50 Shore A
Material:
Medical Grade Liquid Silicone Rubber
Tear Strength:
25 KN/m
Tensile Strength:
8 MPa
Density:
1.11 G/cm³
Certificate:
ISO13485, RoHS, REACH, FDA 21 CFR 177.2600
Advantage:
High Tear Resistance, Platinum Cured
Sample:
Free Offered
Hardness:
50 Shore A
Material:
Medical Grade Liquid Silicone Rubber
Tear Strength:
25 KN/m
Tensile Strength:
8 MPa
Density:
1.11 G/cm³
Certificate:
ISO13485, RoHS, REACH, FDA 21 CFR 177.2600
Advantage:
High Tear Resistance, Platinum Cured
Sample:
Free Offered
FDA 21 CFR 1772600 Medical Garde Material Density 111 Gcm3 Suitable for Food Contact and Medical Equipment Manufacturing

Product Description:

6250‑50YHAB is RUIHE premium platinum‑cured medical‑grade liquid silicone rubber, which is specially developed for strict medical‑healthcare scenarios. As 100% silicone formulation, it delivers reliable biocompatibility and high purity for critical medical end‑uses.

Besides outstanding high transparency for visual inspection and aesthetic requirements, this material also keeps stable mechanical performance including good flexibility and wear resistance. Meanwhile, it fully complies with ISO13485, RoHS, REACH and FDA 21 CFR 177.2600 certifications, so manufacturers can meet global regulatory requirements for patient safety.

 

It features fast curing within 15‑30 seconds, which greatly lifts production efficiency and cuts energy costs for high‑volume manufacturing, yet it will not sacrifice final‑part performance. Its low‑to‑medium viscosity ensures favorable flow‑ability, thus supporting precise molding for complex, intricate components and lowering product defects.

 

Thanks to platinum‑cured system, this LSR gains good chemical resistance and thermal stability. It can endure repeated sterilization such as autoclaving, gamma radiation and EO treatment without degradation, while fewer residual impurities further improve biocompatibility.

Therefore, it fits widely for medical seals, gaskets, tubing, catheters and other healthcare parts. Balancing high transparency, fast processing, full compliance and sterilization resistance, 6250‑50YHAB is a dependable material for medical device manufacturers.

 

Features:

  • Product Name: Medical Grade Silicone Rubber
  • Viscosity: Low‑Medium
  • Hardness: 50 Shore A
  • Feature: Fast Curing
  • Certificate: ISO13485, RoHS, REACH, FDA 21 CFR 177.2600
  • Tear Strength: 25 KN/m
  • Made from 100% silicone rubber material for superior quality
  • Excellent aging resistance for long-lasting performance
  • Contains 100% silicone rubber material ensuring biocompatibility
 

Technical Parameters:

Material Medical Grade Liquid Silicone Rubber (100% silicone rubber material, good resilience, yellowing resistance)
Food Contact Approval FDA 21 CFR 177.2600
Color Slightly Bluish‑transparent
Tensile Strength 8 MPa
Tear Strength 25 KN/m
Viscosity Low‑Medium
Package 20kg A+B Per Drum
Advantage High Tear Resistance, Platinum Cured
Certificate ISO13485, RoHS, REACH, FDA 21 CFR 177.2600
Sample Free Offered
 

Applications:

RUIHE 6250‑50YHAB is an advanced two‑component medical‑grade silicone rubber produced in Guangzhou, China. Built for high‑requirement medical scenarios, it complies with ISO13485, RoHS, REACH and FDA standards to guarantee safety for healthcare‑related products.

 

Since it features great yellowing resistance, it can retain stable clarity and performance even after long‑term exposure and repeated sterilization. With 25 kN/m tear strength and 8 MPa tensile strength, this platinum‑cured material also delivers excellent resilience and durability for medical‑grade usage.

 

Moreover, its fast‑curing property of 15‑30 seconds greatly improves manufacturing efficiency. Packed in 20kg A+B drums, it enables simple mixing and stable output. We offer 10000 kg monthly supply with 7‑15 working‑day delivery to support continuous production.

It is widely applied for medical tubing, seals, gaskets, catheters, prosthetic molds and implant‑related components. Thanks to reliable mechanical performance and full medical certification, it works well for both medical prototyping and mass production.

In short, 6250‑50YHAB integrates anti‑yellowing property, stable resilience and user‑friendly two‑component system, serving as a high‑performance material for diverse medical applications.