Master-Frank N95 Particulate Respirator

K172963 is the FDA 510(k) clearance record for Master-Frank N95 Particulate Respirator, a class II device, cleared for Master & Frank Enterprise Co., Ltd. on 2018-04-04 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 one 510(k) clearance for Master & Frank Enterprise Co., Ltd. As of 2026-09-10, FDA records show no recalls naming K172963.