KIMGUARD ONE-STEP STERILIZATION WRAP

KIMGUARD ONE-STEP STERILIZATION WRAP is an FDA 510(k)-cleared medical device (K112805) manufactured by Kimberly-Clark Corp.. 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 June 21, 2012. Regulation: 8.