JOYKEY SURGICAL GOWNS (STERILE)

JOYKEY SURGICAL GOWNS (STERILE) is an FDA 510(k)-cleared medical device (K062479) manufactured by Joykey Industryial , Ltd.. 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 13, 2007. Regulation: 8.