Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement

K071465 is the FDA 510(k) clearance record for BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT, a class I device, cleared for Molnlycke Health Care Us, LLC on 2007-09-11 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 K071465.