SURGEON'S GLOVES

SURGEON'S GLOVES is an FDA 510(k)-cleared medical device (K893522) manufactured by Thai Fuji Latex Co., Ltd.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 1990. Regulation: 8.