O-Rings for Food Safe & Medical Applications
Global O-Ring and Seal offers a wide variety of FDA-compliant products.
There is often confusion around the terms FDA Grade, FDA Compliant, FDA Certified, etc. As a general policy, the Food and Drug Administration does not “certify” o-rings. Rather, they publish guidelines to specify ingredients that can be used in rubber parts which may come in contact with food. It is then the responsibility of the manufacturer to certify that the parts they provide are “FDA Compliant” by issuing a certificate stating such.
What does it mean for a rubber o-ring to be FDA-compliant?
FDA-compliant means passing the Code of Federal Regulations, specifically CFR21.177.2600, which covers:
- Dry Foods: Must meet formulation and curation criteria under conditions of good manufacturing practice as appropriate for repeated use.
- Liquids: Must meet extraction criteria (not exceeding 20mg/sq inch in distilled water).
- Fatty Foods: Must meet additional extraction criteria (not exceeding 175mg/sq inch in n-hexane).
Global O-Ring and Seal offers a range of FDA compliant materials and our FDA Declaration of Compliance can be viewed here.
Our FDA-Compliant Compounds
Here are a few of our standard FDA-compliant o-ring and o-ring cord compounds:
FDA-Grade O-Ring Cord
Note: The Food & Drug Administration does not individually approve specific products to CFR 21.177.2600. The manufacturer of the completed FDA-grade product is the designated entity to furnish an FDA certificate as evidence of its compliance. Furthermore, while a manufactured part may be FDA-grade material, one should not infer that part fits its intended technical application.