FDA and Medical Grade 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.
- Durometer
- Varies by compound (10A to 90A)
- Highlight
- FDA 21 CFR 177.2600
Request a quote for FDA / Medical Grade rubber washers.
Properties of FDA / Medical Grade rubber washers
Cannon Gasket cuts FDA / Medical Grade rubber washers to your specifications in durometers ranging from 10A to 90A. 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 washers land around ±0.010" to ±0.015" on OD and ID, depending on material durometer and thickness. Tighter tolerances are available on selected 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
Standard sizes, tolerances & manufacturing
Precision & tooling: Capable of holding tolerances as tight as ±.001" on critical dimensions when required, beyond the ±0.010" to ±0.015" standard. Short- and long-run capabilities. All parts available with pressure-sensitive adhesive (PSA) on one or two sides.
Clean room: Cannon Gasket offers clean-environment stamping for medical, FDA, electronic, and scientific applications where a controlled level of particulate is required, with capabilities to meet ISO Class 10,000.
Stocking agreements: Blanket orders, VMI (vendor-managed inventory), JIT (just-in-time), and Kanban replenishment programs.
Pad printing: Pad print your part number, identification marking, or company name in a range of ink colors. Marking per customer specifications or MIL-STD-130.
Packaging: Parts are bagged and tagged in specified quantities and labeled with P/N or any required information. Capability to meet specific packaging and labeling requirements.
Standard Screw Size Rubber Washers
| Screw Size | Outside Diameter | Inside Diameter | Thickness |
|---|---|---|---|
| #6 Standard | 0.250" | 0.120" | 0.015" – 0.250" |
| #6 Option | 0.375" | 0.120" | 0.015" – 0.250" |
| #8 Standard | 0.312" | 0.150" | 0.015" – 0.250" |
| #8 Option | 0.438" | 0.150" | 0.015" – 0.250" |
| #10 Standard | 0.375" | 0.170" | 0.015" – 0.250" |
| #10 Option | 0.500" | 0.170" | 0.015" – 0.250" |
| #12 Standard | 0.437" | 0.195" | 0.015" – 0.250" |
| #12 Option | 0.562" | 0.195" | 0.015" – 0.250" |
| #14 Standard | 0.500" | 0.230" | 0.015" – 0.250" |
| #14 Option | 0.625" | 0.230" | 0.015" – 0.250" |
| 5/16" Standard | 0.562" | 0.290" | 0.015" – 0.250" |
| 5/16" Option | 0.688" | 0.290" | 0.015" – 0.250" |
| 3/8" Standard | 0.625" | 0.355" | 0.015" – 0.250" |
| 3/8" Option | 0.812" | 0.355" | 0.015" – 0.250" |
| 1/2" Standard | 1.062" | 0.490" | 0.015" – 0.250" |
| 3/4" Standard | 1.500" | 0.740" | 0.015" – 0.250" |
Standard RMA Thicknesses and Tolerances for Elastomers
| Nominal Thickness | Tolerance |
|---|---|
| 0.015" | ±0.010" |
| 0.031" | ±0.012" |
| 0.062" | ±0.016" |
| 0.093" | ±0.016" |
| 0.125" | ±0.020" |
| 0.187" | ±0.031" |
| 0.250" | ±0.031" |
| 0.375" | ±0.047" |
| 0.500" | ±0.047" |
Standard references shown. Cannon Gasket also cuts custom outside diameters, inside diameters, and thicknesses to your drawing. Send your specifications for a quote.