KIMGUARD ONE-STEP STERILIZATION WRAP

KIMGUARD ONE-STEP STERILIZATION WRAP is an FDA 510(k)-cleared medical device (K141071) 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 July 27, 2014. Regulation: 8.