SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE

SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE is an FDA 510(k)-cleared medical device (K884295) manufactured by Saybrex Intl., Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 7, 1988. Regulation: 8.