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The tables were created to provide easy access to a comprehensive listing of NIOSH approved particulate filtering facepiece respirators and also to provide easy access to the donning process/user instructions. The tables are not updated as frequently as the certified equipment list, which is the official NIOSH certification record.

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The Food and Drug Administration (FDA) is an agency of the U.S. federal government. The FDA is responsible for regulating the safety of food, drugs, cosmetics, biological products, medical devices, and consumer products that emit radiation. It has the power to

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This health care particulate respirator and surgical mask helps provide respiratory protection against certain airborne biological particles. It is disposable and fluid resistant to splash and spatter of blood and other infectious material. This healthcare respirator is designed to

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FDA Regulation of Surgical Masks and Respirators

FDA Regulation of Surgical Masks and Respirators Chiu S. Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control, UNITED STATES AGENT (new requirement) cleared through 510(k) by FDA as surgical mask. 20

Recognized Consensus Standards

The CDRH Standards ProgramCreated as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards.

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