AERO BLUE PERFORMANCE SURGICAL GOWN

AERO BLUE PERFORMANCE SURGICAL GOWN is an FDA 510(k)-cleared medical device (K140539) manufactured by Kimberly-Clark Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2014. Regulation: 8.