KIMGUARD ONE STEP STERILIZATION WRAP

KIMGUARD ONE STEP STERILIZATION WRAP is an FDA 510(k)-cleared medical device (K113806) manufactured by Kimberly-Clark Health Care. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2013. Regulation: 8.