CONVERTORS SMS POLYOLEFIN GOWN

CONVERTORS SMS POLYOLEFIN GOWN is an FDA 510(k)-cleared medical device (K020593) manufactured by Allegiance 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 March 17, 2002. Regulation: 8.