Medical Grade Silicone Rubber

Stockwell Elastomerics manufactures USP Class VI rated silicone rubber gaskets and components for medical device applications that are non-implant and in an area of the device where there is no exchange of blood or bodily fluids. Stockwell Elastomerics’ medical grade compounds are often sterilized using gamma, autoclave and ETO with minimal effect on the rubber compounds. Sample swatches for trial sterilizations and other validation testing are available.

Common medical device applications for USP Class VI rated silicone include enclosure gaskets, housing gaskets, vibration or dampening pads. More often, Stockwell Elastomerics manufactures custom silicone rubber parts for medical device OEMs to their engineering drawings. These custom medical components specify the type and durometer of FDA / USP Class VI rated silicone rubber needed. These parts can be made from FDA grade liquid silicone rubber that can be injection molded or cut from FDA high consistency rubber (HCR). Both of Stockwell Elastomerics’ FDA silicone rubber types (LSR and HCR) are platinum cured, also referred to as addition cured. Platinum cured silicones are preferred for medical device applications because they do not generate organic acids commonly produced with peroxide cured silicone rubber.

FDA High Consistency Rubber (HCR), Silicone

• SSP4749-10 – 10 durometer FDA High Consistency Rubber (HCR)
• SSP4749-20 – 20 durometer FDA High Consistency Rubber (HCR)
• SSP4749-30 – 30 durometer FDA High Consistency Rubber (HCR)
• SSP4749-30LV – 30 durometer High Consistency Rubber (HCR) with Post-Cure
• SSP4749-40 – 40 durometer FDA High Consistency Rubber (HCR)
• SSP4749-50 – 50 durometer FDA High Consistency Rubber (HCR)
• SSP4749-50LV – 50 durometer High Consistency Rubber (HCR) with Post-Cure
• SSP4749-60 – 60 durometer FDA High Consistency Rubber (HCR)
• SSP4749-70 – 70 durometer FDA High Consistency Rubber (HCR)

FDA Grade Liquid Silicone Rubber (LSR)

• SE2010 – 10 durometer liquid silicone rubber (LSR)
• SE2020 – 20 durometer liquid silicone rubber (LSR)
• SE2030 – 30 durometer liquid silicone rubber (LSR)
• SE2040 – 40 durometer liquid silicone rubber (LSR)
• SE2050 – 50 durometer liquid silicone rubber (LSR)
• SE2060 – 60 durometer liquid silicone rubber (LSR)
• SE2070 – 70 durometer liquid silicone rubber (LSR)

Stockwell Elastomerics’ Support for the Medical Device Industry

View Stockwell Elastomerics’ Support for the Medical Device Industry statement regarding fabricated and molded gaskets and related articles used in medical equipment.