N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

K160271 is the FDA 510(k) clearance record for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, a class II device, cleared for San-M Package Co., Ltd. on 2016-07-15 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 3 510(k) clearances for San-M Package Co., Ltd., from 2016-07-15 to 2022-09-16. As of 2026-09-10, FDA records show no recalls naming K160271.