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Gown Testing for FDA Emergency Use Authorization
The product has not been FDA cleared or approved;
The product has been authorized by FDA under an Emergency Use Authorization (EUA) for use as PPE in healthcare settings by HCP as they may help protect HCP and/or patients from the transfer of the SARS-CoV-2 virus in low or minimal risk level situations to prevent the spread of COVID19.
This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak, under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
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