FDA Product Code FRG: Wrap, Sterilization

Sterilization wraps protect instrument sterility between processing and use. FDA product code FRG covers sterilization wraps used to package surgical instruments before steam or EO sterilization.

These nonwoven or woven fabrics provide a microbial barrier that maintains sterility of packaged instruments during storage and transport to the point of use. They must allow sterilant penetration during the cycle while preventing post-sterilization contamination.

FRG devices are Class II medical devices, regulated under 21 CFR 880.6850 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Kimberly-Clark Corp., Medline Industries, Inc. and STERIS Corporation.