Medical Device Gaskets, Washers, and Seals
Cannon Gasket operates an ISO 7 / Class 10,000 clean room with lot-controlled production and ISO 9001 systems. Manufacturing sealing components since 1971. Send device drawings, applicable QMS expectations, and volume for material recommendations, sample parts, and quoted pricing.
- Supporting medical device OEMs, diagnostic instrument builders, and pharmaceutical packaging manufacturers.
- Used for diagnostic instrument seals, drug delivery components, fluid-path seals, and biocompatible diaphragms.
- Fabricated from FDA 21 CFR 177.2600 elastomers, USP Class VI grades, platinum-cure silicone, Kapton, and virgin PTFE.
Request a quote for Medical projects.
Sealing components for medical
Medical devices, surgical instrumentation, infusion equipment, and laboratory hardware require sealing components with documented biocompatibility, low extractables, and contamination-controlled manufacturing. Cannon Gasket supplies custom medical-grade components from our Class 10,000 (ISO 7) clean room with full documentation.
Where medical sealing shows up
- Diagnostic instrument gaskets and seals
- Drug delivery device components
- Fluid-path seals in lab and analytical equipment
- Pharmaceutical processing gaskets
- Drug-delivery and diagnostic components (USP Class VI)
- Biocompatible silicone diaphragms
Sealing Applications and Material Fit
Surgical instrument seals are die-cut from platinum-cured silicone and USP Class VI compounds, while infusion and drug delivery components use FDA-grade silicone selected for low extractables. Diagnostic equipment relies on Kapton, Mylar, and FDA silicone for sensor and reagent contact, where dimensional stability and clean material contact matter. Laboratory instrument seals use chemical-resistant PTFE and Viton in FDA grades to hold up against reagents and solvents. Disposable assembly components are die-cut and kiss-cut from FDA silicone, EPDM, and TPE for high-volume single-use parts.
Materials We Supply for Medical
Cannon stocks USP Class VI platinum-cured silicone, FDA-grade silicone, FDA EPDM, FDA Buna-N (where appropriate), and polyisoprene that is latex-protein-free for applications sensitive to latex proteins. For higher-temperature, chemical, and dimensionally stable needs, we supply Kapton, PTFE (FDA and virgin), and Mylar. Material selection follows the device requirement, matching biocompatibility grade, chemical exposure, and contact surface to the right compound rather than a single default elastomer.
Production and Quality Considerations
Manufacturing and packaging take place in a Class 10,000 (ISO 7) clean room, with USP Class VI biocompatibility documentation available for qualifying compounds. Every run carries lot-level traceability with pad-printed lot codes so parts can be tied back to their source material. Cannon Gasket is ISO 9001 certified, with production aligned to medical device manufacturer quality systems. Sterilization-compatible compound recommendations for autoclave, EtO, and gamma processes are available on request.