Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

K191869 is the FDA 510(k) clearance record for Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim, a class I device, cleared for Molnlycke Health Care Us, LLC on 2020-03-13 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 27 510(k) clearances for Molnlycke Health Care Us, LLC, from 2006-12-20 to 2023-09-15. As of 2026-09-10, FDA records show no recalls naming K191869.