STERILE CONVERTOR SAFECARE GOWN AND DRAPE

STERILE CONVERTOR SAFECARE GOWN AND DRAPE is an FDA 510(k)-cleared medical device (K920837) manufactured by Baxter 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 May 21, 1992. Regulation: 8.