FDA and Medical Grade Rubber Gaskets
When the gasket is in direct contact with food, beverage, pharmaceuticals, drinking water, or a medical device, the compound must be more than a generic elastomer — it must be a documented FDA or medical-grade formulation. Cannon Gasket die-cuts custom FDA and medical-grade rubber gaskets 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
- 10A to 90A
- Highlight
- FDA 21 CFR 177.2600 compliant
Request a quote for FDA Medical Grade gaskets.
Properties of FDA Medical Grade gaskets
Cannon Gasket cuts FDA Medical Grade gaskets to your specifications in durometers ranging from 10A to 90A Shore hardness. Material selection matches FDA, NSF, or USP Class VI requirements per application.
FDA Medical Grade tolerances and customization
Standard dimensional tolerances on FDA Medical Grade gaskets 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 — broad temperature range, the default for food and pharmaceutical contact. - Platinum-cured silicone — for medical implant and tubing-adjacent applications. - FDA-grade EPDM — for water and steam contact in drinking water and beverage systems. - FDA-grade neoprene and Buna-N — for oil or fuel contact in regulated food machinery. - USP Class VI compounds available on request for medical device contact.
Where FDA / Medical Grade Gaskets Are Specified
Food and beverage processing equipment, pharmaceutical mixers and reactors, drinking water systems, milk and dairy fittings, surgical instrumentation, infusion devices, drug-delivery components, and any application where compliance documentation must accompany the gasket.
Documentation and Traceability
We provide compound data sheets, FDA letter compliance documentation, and lot-level traceability on every FDA / medical-grade production run. Pad printing with lot codes and clean room packaging is standard.
Manufacturing Methods
Die-cut, compound-die-cut, lathe-cut, and rotary-cut.
Medical and healthcare applications
Cannon Gasket services a large portion of the medical and healthcare industries, providing gaskets and washers made from materials suitable for medical diagnostics, instrumentation, implantable devices, skin contact, and hypoallergenic applications.
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 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.