Single-Use Latex Sterile Surgical Gloves (SG100)

K231446 is the FDA 510(k) clearance record for Single-Use Latex Sterile Surgical Gloves (SG100), a class I device, cleared for Fitone Latex Products Co., Ltd. Guangdong on 2023-09-22 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 4 510(k) clearances for Fitone Latex Products Co., Ltd. Guangdong, from 2021-10-12 to 2023-09-22. As of 2026-09-10, FDA records show no recalls naming K231446.