CONVERTORS POLYOLEFIN FABRIC GOWNS

CONVERTORS POLYOLEFIN FABRIC GOWNS is an FDA 510(k)-cleared medical device (K961341) 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 October 27, 1996. Regulation: 8.