DEROYAL GOWNS, STERILE, NON-STERILE

DEROYAL GOWNS, STERILE, NON-STERILE is an FDA 510(k)-cleared medical device (K030364) manufactured by Deroyal 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 April 27, 2003. Regulation: 8.