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N95 Respirators in Industrial and Health Care Settings

Updated: Jan 16, 2022

The majority of N95 respirators are designed for use in construction and other industrial jobs where employees are exposed to dust and tiny particles. They are governed by the National Personal Protective Technology Laboratory (NPPTL), which is part of the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (NIOSH) (CDC)

Some N95 respirators, on the other hand, are designed for usage in a medical context. Single-use, disposable respiratory protection devices used by health care staff during procedures to protect both the patient and the health care personnel from the transmission of germs, bodily fluids, and particulate matter. The FDA regulates these surgical N95 respirators under 21 CFR 878.4040, while the CDC NIOSH regulates them under 42 CFR Part 84. N95s respirators with the product code MSH are class II medical devices that are exempt from 510(k) premarket notice unless they meet the following criteria:

  • The respirator is designed to protect you from certain diseases or infections, or

  • The respirator is advertised as filtering surgical smoke or plumes, filtering specified levels of viruses or bacteria, decreasing and/or destroying viruses, bacteria, or fungi, or influencing allergenicity, or

  • Coating technologies unrelated to filtration are included in the respirator (e.g., to reduce and or kill microorganisms).

The FDA and the CDC's National Institute of Occupational Safety and Health (NIOSH) have signed a Memorandum of Understanding (MOU) that provides the framework for FDA and NIOSH coordination and collaboration in the regulation of this subgroup of N95 respirators.

Please visit the CDC's infographic for more details on the differences between surgical masks and N95 respirators.


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