Pfr95 Particulate Filter Respirator and Surgical Mask Regular Size, Pfr95 Particulate Filter Respirator and Surgical

K974068 is the FDA 510(k) clearance record for PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL, a class II device, cleared for Tecnol Medical Products, Inc. on 1997-12-22 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 21 510(k) clearances for Tecnol Medical Products, Inc., from 1992-10-05 to 1997-12-22. As of 2026-09-10, FDA records show one recall naming K974068.