Biogel Neotech II Powder-Free Neoprene Surgeon's Glove

K000421 is the FDA 510(k) clearance record for BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE, a class I device, cleared for Ssl Americas, Inc. (Regent Medical) on 2000-08-14 under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list one 510(k) clearance for Ssl Americas, Inc. (Regent Medical). As of 2026-09-10, FDA records show one recall naming K000421.