GORE-TEX NON-STERILE SURGICAL GOWNS

GORE-TEX NON-STERILE SURGICAL GOWNS is an FDA 510(k)-cleared medical device (K052833) 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 February 14, 2006. Regulation: 8.