This product has been tested and meets the NIOSH standard of Surgical N95. The surgical N95 has demonstrated conformance to FDA specified requirements and is intended for use in all healthcare settings and for all medical purposes in which an N95 level of respiratory protection is needed to protect the wearer. They are extremely durable with a soft and comfortable inner surface,also have an adjustable nose piece and secured head straps to provide proper fit. These masks have a 510(K) number for the medical market and can be used TB situations as recommended by OSHA.