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FDA grade O-ring
O-rings for food safety and medical applications---FDA grade O-ring
Lanhe O-rings and seals are available in a wide range of FDA-compliant products.
Terms such as FDA grade, FDA compliance, and FDA certification often cause confusion. As a general policy, the U.S. Food and
Drug Administration does not "certify" O-rings. Instead, they issued guidelines to specify ingredients that can be used in rubber
parts that may come into contact with food. The onus is then on the manufacturer to prove that the part they supply "meets
FDA standards" by issuing a certificate.
What does it mean that rubber O-rings meet FDA standards?
FDA compliance means passing federal regulations, specifically CFR21.177.2600, which cover:
1.Dry food:
must comply with good manufacturing practice conditions of formulation and management standards, suitable for reuse.
2.Liquid:
Must meet extraction criteria (no more than 20 mg/sq. inch in distilled water).
3.Fatty foods:
Additional extraction criteria must be met (no more than 175 mg/sq. inch in n-hexane).
Lanhe O-rings and Seals offers a range of FDA-compliant O-rings and O ring cord.
LANHE meets FDA elastomers:
Here are the materials we provide for common rubber O-rings that meet FDA standards.
Note: The U.S. Food and Drug Administration (FDA) has not individually approved specific products in CFR 21.177.2600. Manufacturers of complete FDA grade products are designated entities that provide FDA certificates to demonstrate their compliance. In addition, although a manufactured part may be an FDA-grade material, it should not be inferred that the part meets its intended technical application.
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