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    FDA Authorized

    FDA Headquarters sign

    My BFF Maskshave been Authorized by the FDA for use by members of the general public, including health care personnel (HCP) in healthcare settings as Personal Protective Equipment (PPE), to cover their noses and mouths, In accordance with Centers for Disease Control and Prevention (CDC) recommendations, to Prevent the spread of the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the Coronavirus Disease 2019 (COVID-19) pandemic, pursuant to section 564 of the Federal, Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3).

    (NOTE: The Seasonal Flu virus would be included, To Prevent a “Twindemic”, where people are infected with both viruses at the same time, which could increase the severity of disease.)   

    • Scope of Emergency Use Authorization (EUA): My BFF Masks is limited to use as source control for members of the general public, including health care personnel (HCP) in healthcare settings, to cover their noses and mouths, in accordance with CDC recommendations, to prevent the spread of the SARS-CoV-2 during the COVID-19 pandemic.
    • Materials: Layer 3 (touches the skin): 95% Cotton/5% poly blend, layer 2: ToolBox brand blue shop towel sheets that are a non-woven material through which you cannot see sparkles of light and have excellent breathability, and Layer 3 (top, color layer): A variety of fabric formulations, both natural and synthetic including Polyester, nylon and Spandex.
    • Recommended Use: My BFF Masks are recommended for use as source control* for members of the general public, including health care personnel (HCP) in healthcare settings to help reduce person-to-person transmission.
    *Source control refers to the use of a facemask or cloth face covering over the mouth and nose to contain that individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have symptoms of COVID-19 and the seasonal flu virus.
    • Unauthorized Use: My BFF Masks are not recommended for use
      • in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected,
      • in a clinical setting where the infection risk level through inhalation exposure is high, or
      • in the presence of a high intensity heat source or flammable gas.
    • Cleaning and Care: For recommended cleaning and care instructions, please Click Here.
    • Adverse event reporting: If you experience any adverse events associated with the use of this product, please click here to fill out a complaint form.
    • This product has not been FDA cleared or approved.