Powdered Sterile Latex Surgical Glove, with Protein Content Labeling Claim (200 Micrograms or Less)

K001959 is the FDA 510(k) clearance record for POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS), a class I device, cleared for Hartalega Sdn Bhd on 2000-07-26 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 61 510(k) clearances for Hartalega Sdn Bhd, from 1989-05-31 to 2020-10-02. As of 2026-09-10, FDA records show no recalls naming K001959.