FDA, USDA, NSF51, USP Class VI Approved

The Food and Drug Administration (FDA) has established a list of rubber compounding ingredients which tests have indicated are neither toxic nor carcinogenic. Rubber compounds produced entirely from those ingredients and which also pass the FDA extraction tests are said to 'meet the FDA requirements.' The FDA does not approve rubber compounds. It is the responsibility of the manufacturer to compound food grade materials from the FDA list of ingredients and establish whether they pass the necessary extraction requirements. Similar standards are established by the United States Department of Agriculture (USDA).

Additional requirements have been imposed upon seal manufacturers regarding food and beverage service. Parker has developed several materials that are certified to NSF 51, Food and Beverage Standard. In critical medical applications, seals often must be made from an even 'cleaner' list of ingredients. The U.S. Pharmacopoeia (USP) Class VI outlines requirements for system toxicity and intracutaneous toxicity for these 'cleaner' compounds. The USP Class VI compounds must be made from ingredients with clear histories of biocompatibility that meet tighter requirements for leachates.

Typical applications for our FDA, NSF 51, USDA materials are disposable medical devices, surgical instruments and medical fluid dispensing components, as well as a wide variety of food and beverage handling equipment. The type of approval/certification required generally rests with the end customer's regulatory expectations for the specific application.



E1028-70  EPDM  70  Black  FDA
E1549-70(63447)  EPDM  70  Black  NSF 51
 E1583-70 (63017)  EPDM  70  Black  NSF 51
 E3609-70  EPDM  70  Black  NSF 51, FDA,
          USP Class VI
EJ150-75 (3077)  EPDM  75  Black  FDA, USP Class VI
 FF200-75  FFKM  75  Black  FDA
 FF350-75  FFKM  75  White  FDA, USP Class VI
 FF500- 75  FFKM  75  Black  FDA
 V8545- 75  FFKM  75  Black  FDA
 V8562- 75  FFKM  75  White  FDA
 HF351- 65  FKM  65  Translucent  FDA, USP Class VI
 V0680- 70  FKM  70  Red  NSF 51, FDA, USDA
 N1219- 60  NBR  60  Black  NSF 51, FDA
 N1069- 70  NBR  70  Black  FDA
 N1220- 70  NBR  70  Black  NSF 51, FDA
 NJ253-70 (7077)  NBR  70  Black  FDA
 N0508- 75  NBR  75  Black  FDA, USDA
 S0802- 40  VMQ  40  White  FDA
 SM151-50 (11355)  VMQ  50  Rust  FDA
 S1538- 55  VMQ  55  Translucent  FDA, USP Class VI
 SM152-60 (11356)  VMQ  60  Rust  FDA
 S0317- 60  VMQ  60  Rust  FDA, USDA
 S1138- 70  VMQ  70  Rust  FDA
 SM153-70 (11357)  VMQ  70  Rust  FDA
 S0355- 75  VMQ  75  Rust  FDA, USDA