
American Convertors Div., American Pharmaseal
Free shipping on orders over $99 · 30-day returns
SHIELD DISP. PATIENTS PONCHO GOWNS is an FDA 510(k)-cleared medical device (K801570) manufactured by American Convertors Div., American Pharmaseal. 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 July 27, 1980. Regulation: 8.