FDA Materials

The rubber compounds in the following list all comply with Paragraph 177.2600 of Title 21, sub-paragraphs a) through d), Code of Federal Regulations, "Rubber Articles Intended for Repeated Use". It should be noted that the Food and Drug Administration does not actually approve any rubber compounds. Rather it publishes a list of permissible ingredients and the maximum allowable concentration of each. These ingredients are broken down into the following categories: Elastomers, Vulcanization Agents, Accelerators, Retarders, Activators, Antioxidants and Antizonants, Plasticizers, Fillers, Colors, Lubricants, Emulsifiers, and Miscellaneous. It is the responsibility of the manufacturer, or its compound supplier, to ensure that FDA compounds are formulated according to these guidelines, and are cured under conditions of good manufacturing practices.

Unless otherwise specified, all compounds in the list are black in color and sulfur cured. In addition to these 28 compounds, all of RT/Dygert's NSF (National Sanitation Foundation) certified compounds also meet FDA requirements. Finally, nearly all of our silicone compounds are also FDA compliant.