Medical Grade Silicone is the Material of Choice for Medical Device Components
Medical Grade Silicone is used in implantable and disposable medical devices that require high performance and safety when in short or long term contact with the human body.
- Silicone has no side effects and can be sterilized.
- When finished, a silicone component will retain its shape under pressure and temperature extremes and resist tearing.
- We use only medical-grade silicone rubber, which meets or exceeds all USP Class VI test requirements. We do not use organic rubber compounds such as latex in our facilities.
- Our technical specialists work with each client to select the optimal grade of silicone for the application, based on our understanding of how best to formulate, handle and process medical silicone rubber.
- When suitable, we prepare our silicone mixtures in automatic centrifugal mixers in Class 5 (100) clean rooms and track each batch through lot-tracing, barcoding and shelf-life management.
Silicone Materials and Additives
- Liquid silicone rubber (LSR)
- High consistency silicone rubber (HCR or gum stock)
- Transparent silicone, fabricated for high-refractive index and optically clear applications
- Pigmented silicone, including custom Pantone colors and radio-opaque tracers
- Silicone infused with desiccants using FMI’s proprietary process
- Antimicrobial agents
For ready availability, we stock both high consistency silicone rubber (HCR or gum stock) and liquid silicone rubber (LSR), which minimizes lead times and reduces costs for our clients. We are happy to accommodate a client’s preferred supplier and material specifications.
We works with the world’s leading suppliers of medical grade silicone, including:
- NuSil Technology
- Dow Corning Silicones
- Momentive Performance Materials (GE Silicones)
- Shincor Silicones (ShinEtsu)
- Wacker Silicones