Regent Biogel Surgical Glove, Biogel M Glove

K970924 is the FDA 510(k) clearance record for REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE, a class I device, cleared for Regent Medical on 1997-04-01 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 Regent Medical. As of 2026-09-10, FDA records show no recalls naming K970924.