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 O&M Halyard, Inc., Medline Industries, LP and Steris.
List of Wrap, Sterilization devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Wrap, Sterilization devices (product code FRG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →