This high quality, non-woven polypropylene ICU Face Mask is designed with 3-layer construction for breathability. The ICU Face Mask features fluid-resistance and is latex-free. Featuring soft edging and an adjustable nose for form-fit, wear-ability and comfort, the ICU Face Mask is non-sterile and designed for non-medical applications.
• The product has not been FDA cleared or approved
• The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic.
• This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Not recommended for use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids may be expected, or use in a clinical setting where the infection risk level through inhalation exposure is high, or use in the presence of a high intensity heat source or flammable gas.
The masks are manufactured in China for ICU Health, an FDA registered company located in Hollister, California, USA.
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