Level 3 Reusable Isolation Gown

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Gown Testing for FDA Emergency Use Authorization

• Our gowns meet these Standards for Level 3 Protective Gowns: 
• Passes AATCC 42 Water Resistance Test on as Received and after 3x Laundering Cycles | Passes AATCC 127 Hydrostatic Pressure Test on as Received and after 3x Laundering Cycles | Meet Requirements for Flammability as defined by 16 CFR 1610     

Compliance

• This gown is compliant with the FDA’s Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency, dated March, 2020. It has specifically met test standards at an accredited laboratory to ensure the product’s high performance against specific level 3 tests.
• These products are only recommended for use when standard apparel is unavailable, and only during the duration of the COVID-19 Public Health Emergency / the duration of the FDA’s Enforcement Policy.
• Test Data Sheet available upon request. 

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.