Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves

K160781 is the FDA 510(k) clearance record for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves, a class I device, cleared for Semperit Investments Asia Pte , Ltd. on 2017-05-02 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 Semperit Investments Asia Pte , Ltd., from 2017-05-02 to 2023-01-27. As of 2026-09-10, FDA records show no recalls naming K160781.