FDA Medical Grade Gaskets
Key Properties
- Durometer: 10A – 90A
- FDA 21 CFR 177.2600 compliant
- USP Class VI grades available
- Steam sterilizable
- Inert and biocompatible
- Clean room manufacturing
Why specify FDA Medical Grade for 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.
Properties of FDA Medical Grade gaskets
Cannon Gasket cuts FDA Medical Grade gaskets to your drawing in durometer and thickness specifications of 10A to 90A Shore hardness. Inert to most food contact substances; excellent resistance to moisture, steam sterilization, and moderate chemicals. 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 gasketsland 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 — 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.
Applications
- Food processing equipment
- Beverage production
- Medical devices
- Pharmaceutical manufacturing
- Diagnostic equipment
- Clean room assemblies
Industries Served
- Food & Beverage
- Medical
- Pharmaceutical
- Diagnostics
- Biotech
- Clean Room
Manufacturing Capabilities
- Precision die cutting
- Clean room production (ISO 7)
- Custom shapes & profiles
- In-house tooling
- PSA backing available
- ISO 9001 certified
909.355.1547
sales@cannongasket.com
https://cannongasket.com/gaskets/fda-medical-grade-rubber-gaskets/
