Inovel Health Care Model N95 Particulate Respirators and Surgical Masks

K051182 is the FDA 510(k) clearance record for INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, a class II device, cleared for Inovel, LLC on 2005-05-19 under FDA product code MSH (Respirator, Surgical). FDA's definition for product code MSH reads: "A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific...". FDA records list 7 510(k) clearances for MOLDEX/METRIC, INC., from 2004-09-30 to 2010-09-13. As of 2026-09-10, FDA records show one recall naming K051182.