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This product is authorized by the FDA as a surgical mask under EUA for use in healthcare settings by HCP as PPE 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. This product has not been FDA cleared or approved.
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Lightweight. Easy on & off design with ear loops to secure fit
Comfortable and non-irritating, and not made with natural rubber latex
Non-sterile
Pleated design fits wide variety of faces
ASTM Level 3 Performance
Included in box: 50, included in carton: 2000
Full Berry Certificate available
All direct and indirect skin contacting materials are biocompatible per ISO 10993. List of body contacting materials below.
Outdoor Research Surgical Masks have not been FDA cleared or approved. Outdoor Research Surgical Masks are authorized by the FDA 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. They are intended to be used when FDA-cleared surgical masks or FDA cleared or authorized respirators are not available. The Outdoor Research Surgical Mask is a loose-fitting device worn over the user’s nose and mouth. Surgical Masks may be effective in blocking splashes and large-particle droplets; however, because of the loose fit between the surface of the surgical mask and the user’s face, leakage can occur around the edge of the mask when the user inhales. Therefore, a surgical mask may not provide the user with a reliable level of protection from inhaling smaller airborne particles and is not considered respiratory protection. For this reason, surgical masks are not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure. In such clinical conditions, a filtering facepiece respirator (such as an N95 respirator) with a tight fit is recommended to provide a more reliable level of respiratory protection against pathogenic biologic airborne particulates.
All direct and indirect skin contacting materials are biocompatible per ISO 10993.