Engineered for medical and skin-contact applications, this high tear strength platinum-catalyzed silicone rubber provides exceptional mechanical durability combined with the biocompatibility required for long-term patient contact. It is a two-part, addition-cure elastomer that vulcanizes without releasing any toxic by-products, ensuring that the cured material meets Class VI USP and ISO 10993-5, -10 biocompatibility standards.
The standout feature of this grade is its remarkable tear resistance—significantly higher than standard medical silicones—allowing prosthetics, orthotics, and wearable medical devices to withstand repetitive stretching, twisting, and cleaning cycles. When combined with an elongation at break that routinely exceeds 800%, the material can be repeatedly deformed and still recover completely without cracking or tearing. This makes it ideal for dynamic applications such as prosthetic liners, burn scar dressings, and wearable sensor holders that move with the body.
Despite its impressive mechanical strength, the cured silicone remains soft and compliant at Shore A 5–15 hardness, providing cushioning comfort and minimizing pressure points. The mixed compound has a medium viscosity suitable for both manual lay-up and injection molding processes. Pot life is adjustable from 15 to 60 minutes via the catalyst ratio, and the rubber can be fully cured at room temperature or accelerated with heat (commonly 10 minutes at 120°C). The translucent formulation accepts medical-grade pigments, allowing manufacturers to create custom skin-tone matches or color-coded components.
This platinum silicone is inherently hypoallergenic, resists bacterial growth, and withstands repeated sterilization by steam autoclave, ethylene oxide, and gamma irradiation without degradation. Its surface is non-tacky to the touch, reducing patient discomfort and minimizing lint and dust attraction during daily wear. For companies developing next-generation wearable health monitors, prosthetic sleeves, respiratory masks, or orthotic inserts, this material provides a clinically validated, durable, and patient-friendly solution that helps accelerate regulatory submissions and market entry.
