Document 2JOjj8a9VZqOEn2OYJKwLx7dL

J | BFGoodrich The BFGoodrich Company Geon Vinyl Division 6100 Oak Tree Boulevard Cleveland, Ohio 44131 216-447-6000 April 5, 1993 Marty Vistins Becton Dickinson Worldwide Medical Gloves 14300 Winchester Blvd. Los Gatos, CA 95030-1888 Dear Mr. Vistins: At the request of Ralph Purtell I am providing you with some general information on the FDA status of Geon E-10 and a determination of the clearance of this PVC resin under 21CFR177.2600, rubber articles intended for repeated use. It is my understanding that you are interested in using Geon E-10 in a glove application intended for repeated use in contact with food. Geon E-10 is a polyvinyl chloride (PVC) homopolymer. This resin is "prior sanctioned" for use in general food contact applications, both flexible and rigid. The "prior sanctioned" status of Geon E-10 is based on an article by A. J. Lehman, from the FDA (Journal of the Association of Food and Drug Officials, July, 1951), on the use of PVC in food contact applications and compliance with Good Manufacturing Practice (GMP) specifications (maximum volatility of 3.0%, 1 hour at 105* C, and an inherent viscosity of not less than 0.35 by ASTM D-1243-79) which were established in 1963 by. a knowledgeable group of industry representatives under the auspices of the Society of Plastics Industries, Inc. Because of its "prior sanctioned" status, Geon E-10 is acceptable for use, not only under those sections where PVC is specifically listed, but under those sections which allow the use of "prior sanctioned" materials. One example of such clearance is 21CFR 177.2600 (rubber articles intended for repeated use). This section states that "Substances employed in the preparation of rubber articles include, subject to any limitations prescribed, substances used in accordance with the provisions of a prior sanction or approval." Please contact me at (216) 447-7831 if you have any further questions. Sincerely, Q^T/l4.LjjL ^ < --- Connie N. Dillon Regulatory and Data System Specialist CND/rm 0405.CND 21786001 BFG16515 bcc: Mike Marshall Tom Moore Ralph Purtell Joel Simmons J/lUoaf A BFG16516 CT> 03 OJ o VO S PQ 00 OMi CD <oJ> s