FDA / Medical Grade Rubber Washers
Key Properties
- FDA 21 CFR 177.2600
- USP Class VI compliant
- Cleanroom manufactured
- Full lot traceability
- Multiple elastomers
- Biocompatible
Why specify FDA / Medical Grade for rubber washers?
When a washer is in direct contact with food, beverage, pharmaceutical, drinking water, or a medical device, the compound must be a documented FDA or medical-grade formulation. Cannon Gasket die-cuts custom FDA and medical-grade rubber washers in our Class 10,000 (ISO 7) clean room when contamination control is part of the specification. Latex-free, biocompatible, and 100% virgin PTFE materials are available, with hypoallergenic adhesives on one or two sides.
Properties of FDA / Medical Grade rubber washers
Cannon Gasket cuts FDA / Medical Grade rubber washers to your drawing in durometer and thickness specifications of Varies by compound (10A to 90A). Varies by base elastomer. Silicone offers the broadest temperature range. EPDM provides weather resistance. Viton delivers chemical resistance. All meet FDA food-contact requirements.
FDA / Medical Grade tolerances and customization
Standard dimensional tolerances on FDA / Medical Grade rubber washersland around ±0.010" to ±0.015" on OD and ID, depending on material durometer and thickness. Tighter tolerances are available on select grades. Cannon Gasket cuts FDA / Medical Grade to custom profiles in-house and matches lead times to your production volume. PSA backing, pad printing, custom packaging, and kitting are all on the menu when you need them.
Compounds Available
- FDA-grade silicone (default for food and pharmaceutical contact). - Platinum-cured silicone (medical implant and tubing-adjacent). - FDA-grade EPDM (water, steam, beverage). - FDA-grade Buna-N and neoprene (regulated food machinery with oil contact). - USP Class VI compounds on request.
Common Washer Applications
Food and beverage equipment bolt sealing washers, pharmaceutical mixer and reactor washers, milk and dairy fittings, surgical instrument assemblies, infusion device sealing, drinking-water-rated washers, and any application requiring FDA letter compliance documentation.
Documentation and Traceability
Compound data sheets, FDA letter compliance documentation, USP Class VI letters when applicable, and lot-level traceability. Pad printing with lot codes and clean room packaging is standard.
Manufacturing Methods
Die-cut, compound-die-cut, lathe-cut
Applications
- Medical device assemblies
- Pharmaceutical equipment
- Food processing machinery
- Laboratory instruments
- Biotech equipment
- Surgical devices
Industries Served
- Medical Devices
- Pharmaceutical
- Food & Beverage
- Laboratory
- Biotech
- Healthcare
- Surgical
- Diagnostics
Manufacturing Capabilities
- Cleanroom die cutting
- Custom ID/OD/thickness
- In-house tooling
- Lot traceability
- Prototype to production
- ISO 9001 certified
909.355.1547
sales@cannongasket.com
https://cannongasket.com/rubber-washers/fda-medical-grade-rubber-washers/