FDA / Medical Grade Lathe-Cut Washers
Key Properties
- FDA 21 CFR 177.2600
- USP Class VI compliant
- Full lot traceability
- Multiple elastomers
- Cleanroom manufactured
Why specify FDA / Medical Grade for lathe-cut washers?
When a lathe cut washer is in direct contact with food, beverage, pharmaceutical, drinking water, or a medical device, the elastomer must be a documented FDA or medical-grade formulation. Cannon Gasket lathe cuts FDA and medical-grade washers in our Class 10,000 (ISO 7) clean room when contamination control is part of the specification.
Properties of FDA / Medical Grade lathe-cut washers
Cannon Gasket cuts FDA / Medical Grade lathe-cut washers to your drawing in durometer and thickness specifications of Varies by compound (10A to 90A). Varies by base elastomer. All compounds meet FDA food-contact requirements. USP Class VI biocompatible grades available.
FDA / Medical Grade tolerances and customization
Standard dimensional tolerances on FDA / Medical Grade lathe-cut 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, EPDM, Buna-N, and neoprene tube stock. - Platinum-cured silicone tube for medical implant-adjacent applications. - USP Class VI compounds on request.
Documentation and Traceability
Compound data sheets, FDA letter compliance, USP Class VI letters where applicable, and lot-level traceability with pad-printed lot codes.
FDA and medical materials
Materials include 100% virgin-grade PTFE and FDA-compliant Nitrile/Buna-N, silicone, EPDM, neoprene, and Viton, plus latex-free synthetic rubber compounds. Available with hypoallergenic adhesives on one or two sides for Medical Diagnostics, Instrumentation, Implantable Devices, skin-contact, and hypoallergenic applications.
Applications
- Medical device assemblies
- Diagnostic equipment
- Food & beverage systems
- Pharmaceutical processing
- Laboratory instruments
- Healthcare equipment
Industries Served
- Medical Devices
- Diagnostics
- Food & Beverage
- Pharmaceutical
- Laboratory
- Healthcare
Manufacturing Capabilities
- Lathe cut from extruded tubing
- Cleanroom manufacturing
- Custom ID/OD/thickness
- Lot traceability
- Prototype to production
- ISO 9001 certified
909.355.1547
sales@cannongasket.com
https://cannongasket.com/lathe-cut-washers/fda-medical-grade-cut-washers/