Latex Surgeon Gloves

K901398 is the FDA 510(k) clearance record for LATEX SURGEON GLOVES, a class I device, cleared for Sinochem (Usa), Inc. on 1990-05-16 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 14 510(k) clearances for Sinochem (Usa), Inc., from 1989-06-22 to 1990-06-01. As of 2026-09-10, FDA records show no recalls naming K901398.