FDA Product Code KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Maintaining sterility of surgical instruments between sterilization and use is as important as the sterilization process itself. FDA product code KCT covers sterilization wrap containers, trays, and cassettes.

These rigid or semi-rigid systems protect sterilized instruments from contamination during storage and transport to the point of use. Unlike sterilization wraps, rigid containers provide a durable, reusable barrier that maintains sterility for extended periods.

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

Leading manufacturers include Aesculap, Inc., STERIS Corporation and Summit Medical, Inc..