Precision Associates' Medical Grade silicones are certified by the polymer manufacturer to meet the requirements noted below. All colored compounds use applicable grade polymer and colorants certified to meet USP VI and ISO 10993 requirements. Unless otherwise noted, PAI products made in Medical Grade silicones are manufactured in our ISO 14644-1, Class 7 (10,000) clean room. We use primarily Dow Corning HCR materials in the C-6, Q7-45 & Q7-47 series, but also mold LSR silicones from Nusil, Wacker, Momentive, Elkem, and Shin-Etsu.