Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models Mfrn95-S, Mfrn95-Xs, Mfrn95-Ml, Mfrn95-a

K063747 is the FDA 510(k) clearance record for INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A, a class II device, cleared for Inovel, LLC on 2007-01-12 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 no recalls naming K063747.