Document wrrOJZ4B98ZLqaBdywq2VD6Do

November 20, 1989 Carol Schmidt CL-OTM-3 SUBJECT: GEON RESINS - FDA STATUS Geons 110X902, G-26, 110X406, 110X429, 110X415 are homopolymer PVC resins. Provided they meet the GMP specifications for Prior Sanctioned PVC, they would be acceptable for general food contact. The GMP specifications are: Maximum Volatility 3.0% (1 hour at 105C) Inherent Viscosity not less than 0.35 by ASTM-1243-79-Method A Geon 110X905 contains 0.8 parts of allymethacrylate. A vinyl chloride - allymethacrylate copolymer is listed as acceptable for use only under 21CFR 175.105 "Adhesives". FDA acceptance, or lack of acceptance for food contact, does not mean that the substance in question is, or is not, suitable for medical applications. Each substance must be evaluated on its own, dependent on the intended end use. W. C. Bachtel 91120-2/jp BFG19046 22143001