BREATHABLE IMPERVIOUS GOWNS

BREATHABLE IMPERVIOUS GOWNS is an FDA 510(k)-cleared medical device (K012984) manufactured by Allegiance Healthcare Corp.. 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 September 23, 2001. Regulation: 8.