Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein

K172942 is the FDA 510(k) clearance record for Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein, a class I device, cleared for Beta Healthcare Products Pvt., Ltd. on 2018-01-08 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 one 510(k) clearance for Beta Healthcare Products Pvt., Ltd. As of 2026-09-10, FDA records show no recalls naming K172942.