FDA and Medical Grade 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.
- Durometer
- Varies by compound (10A to 90A)
- Highlight
- FDA 21 CFR 177.2600
Request a quote for FDA / Medical Grade lathe cut washers.
Properties of FDA / Medical Grade lathe cut washers
Cannon Gasket cuts FDA / Medical Grade lathe cut washers to your specifications. 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 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, 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.
Manufacturing, finishing & stocking
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, with an extensive in-house tooling inventory for rapid turnaround.
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.