USP & FDA Specialty Elastomers

USP Class VI Materials

Our offering of United States Pharmacopia (USP) XXII Class VI materials have been tested to (USP) XXII Class VI testing requirements which include: System Toxicity, and Intracutaneous Toxicity. Products are sold as industrial grade products only, for use in non-implant devices. It is the customer s responsibility to determine the suitability of products for each specific application and to comply with all applicable statutory, regulatory, and health care industry requirements and/or standards for efficacy, labeling, safety and testing. USP Class VI materials and products have batch traceability (CBI) for each lot of product produced.

FDA  White List Materials

FDA  White List materials are formulated exclusively from ingredients listed in Federal Regulation Title 21  Food and Drugs, CFR 177.2600,  Rubber Articles Intended for Repeated Use, and have batch traceability. Please note that 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 requisite requirements.