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 Primed Medical Products, Inc..
FDA 510(k) Cleared Wrap, Sterilization Devices (Product Code FRG)
About Product Code FRG - Regulatory Context
510(k) Submission Activity
320 total 510(k) submissions under product code FRG since 1976, with 320 receiving FDA clearance (average review time: 140 days).
Submission volume has increased in recent years - 20 submissions in the last 24 months compared to 15 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FRG have taken an average of 186 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
FRG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →