PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS

PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS is an FDA 510(k)-cleared medical device (K043017) manufactured by Medline Industries, Inc.. 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 March 7, 2005. Regulation: 8.