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FDA Updates Letter to Health Care Personnel and Facilities

August 26, 2022

The U.S. Food and Drug Administration (FDA) has made an update to a letter it first released on May 27, 2021, by removing surgical respirators from the device shortage list. The agency will continue to monitor the supply chain and update the device shortage list as new information becomes available.

The FDA recommends that health care facilities increase their inventory of respirators approved by the National Institute for Occupational Safety and Health (NIOSH), including elastomeric respirators without exhalation valves that can be used in operating rooms. ElastoMaskPro is a NIOSH-approved reusable elastomeric respirator designed without an exhalation valve, allowing users to perform tasks in a hygienic field. Exhalation passes through highly breathable Filter Puck technology.

The FDA letter to health care personnel and facilities released last summer revoked Emergency Use Authorizations for non-NIOSH-approved disposable respirators and decontaminated disposable respirators.

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