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  1. Coronavirus (COVID-19) and Medical Devices

Considerations for Selecting Respirators for Your Health Care Facility

FDA has authorized the emergency use of certain filtering facepiece respirators (FFRs) for use in health care settings by health care personnel (HCP) in accordance with the Centers for Disease Control and Prevention (CDC) recommendations to prevent HCP exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak. In accordance with CDC Strategies for Optimizing the Supply of N95 Respirators, this flowchart and the information below illustrates which Emergency Use Authorization (EUA) applies to specific respirator types and provides links to information on performance factors for each type to consider when selecting respirators for use in health care facilities in the United States.

The FDA, in conjunction with the Centers for Disease Control and Prevention (CDC), and the National Institute for Occupational Safety and Health (NIOSH), continues to evaluate respirator performance.

  1. What to use: National Institute for Occupational Safety and Health (NIOSH) Approved Air Purifying Respirators (includes those that are FDA-cleared and authorized under the EUA such as disposable filtering facepiece respirators (FFRs) (such as N95s) and reusable respirators such as elastomeric and powered air purifying respirators (PAPRs).
  2. If you are unable to obtain NIOSH-approved respirators: Consider the use of imported FDA EUA authorized non-NIOSH-approved respirators NOT manufactured in China and follow these steps:
  3. If you are unable to purchase an imported NIOSH-approved respirator not manufactured in China: Consider the use of FDA EUA authorized non-NIOSH-approved respirators manufactured in China, including KN95s, and follow these steps:
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