Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove

K130450 is the FDA 510(k) clearance record for SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE, a class I device, cleared for Purna Bina Sdn Bhd on 2014-09-30 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 7 510(k) clearances for Purna Bina Sdn Bhd, from 1989-04-06 to 2014-09-30. As of 2026-09-10, FDA records show no recalls naming K130450.