Medical Grade USP Class VI Silicone

Medical Diagnostics MachineStockwell Elastomerics fabricates medical grade USP Class VI silicone rubber into gaskets, pads, and other parts for medical devices and equipment. These biocompatible elastomers are safe for contact with human skin but are not implantable. They can only be used in an area of the device where there is no exchange of blood or bodily fluids. They have low levels of extractables, chemicals that can migrate from a material at elevated temperatures or with surface exposure. USP Class VI silicones can be sterilized using gamma radiation, autoclaving, or ethylene oxide (ETO) gas with minimal effect on material properties.

Testing, Validation, and Medical Device Applications

For trial sterilizations and other validation testing, Stockwell Elastomerics can provide sample swatches of medical grade materials. Custom silicone gaskets and pads for medical device OEMs are manufactured according to specifications that include the specific type and durometer of the FDA / USP Class VI-rated silicone rubber that is needed. Common medical device applications for USP Class VI silicone elastomers include enclosure gaskets, housing gaskets, and vibration or dampening pads.

FDA Grade Liquid Silicone Rubber (LSR) and FDA Grade High Consistency Rubber (HCR)

Stockwell Elastomerics injection molds parts from FDA grade liquid silicone rubber (LSR) and fabricates medical gaskets from high consistency silicone rubber (HCR) using flash cutting, die cutting, and waterjet cutting. These FDA grade LSR and HCR medical silicones are platinum cured or addition cured for cleanliness and purity. Platinum cured silicones are preferred for medical device applications because they do not generate organic acids that are 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.


Contact Stockwell Elastomerics for Medical Grade USP Class VI Silicone

Stockwell Elastomerics has LSR and HCR USP Class VI silicone in stock and molds and fabricates these FDA grade materials to exacting standards. Contact Us for further assistance with USP Class VI rated silicone rubber gaskets and silicone rubber components for medical device applications that are non-implant and do not contact blood or bodily fluids.