Umbrella EUA for Surgical Masks

On August 5, 2020, the FDA issued an umbrella emergency use authorization (EUA) for certain disposable, single-use surgical masks in response to concerns relating to insufficient supply and availability of such masks. This EUA authorizes the use of surgical masks that meet certain performance requirements for use in healthcare settings by health care personnel as personal protective equipment to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.

HealthTrust is providing this information as a service to its members to alert them to changes in the regulatory requirements for surgical masks that may affect supply during the pandemic.

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