FDA Gasketing Material, Nitrile

FDA Gasketing Material, Nitrile

About 8 years ago, when I had first started blog writing- oh God, don’t remind me it was 8 years ago, I wrote a blog on FDA Gaskets for silicone rubber products. This blog only covered what was available for silicone rubber products. In that blog, we neglected rubber products that are compliant to the FDA standard 21 CFR 177.2600.

What is the 21 CFR(Code of Federal Regulations) 177.2600?

The 21 CFR 177.2600 is a regulatory information about rubber articles that are typically used in food packaging, transportation, or holding areas. It states the ingredients that can be used in the rubber products. This can include fillers, rubbers, curative, and additives that may be used in the rubber formulation for any given compound?

Why two lists of FDA 21 CFR 177.2600?

I made a silicone rubber list, and another list, because frankly almost all types of silicone rubber have ingredients that are approved by the federal regulation. Customers often ask, besides silicone rubber, what other types of rubber are available. Frankly, I wanted to come up with a list myself, so when customers call, I already know that I’ve looked into what is available. 

Rubbers/Gasketing Materials Available for FDA Compliance to 21 CFR 177.2600.

Ethylene Propylene EPDM Rubber,  60A Durometer, 70A Durometer 

-Nitrile (Buna-N),NBR  60A Durometer

-Viton (Fluoroelastomer), FKM, 75A Durometer 

-Neoprene (Chloroprene) CR 40, 50, 60A durometer 

-FFKM Perfluoroelastomer, aka Kalrez (numerous Kalrez products available)

Typical availability of these gaskets is usually designated as a white color. 

More Information

NEDC die-cuts, and waterjet-cuts custom gaskets for many types of customers. For more information on FDA Gaskets, please contact sales@nedc.com.

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