KIMGUARD ONE-STEP Sterilization Wrap

KIMGUARD ONE-STEP Sterilization Wrap is an FDA 510(k)-cleared medical device (K143053) 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 April 2, 2015. Regulation: 8.