theClubhou.se Labs Face Masks have been authorized by the U.S Food and Drug Administration (FDA) under a generally issued Emergency Use Authorization dated April 18, 2020 (EUA), for use by health care personnel (HCPs) in healthcare settings as personal protective equipment (PPE), to help prevent the spread of infection or illness in healthcare settings, and by the general public, to help slow the spread of the SARS-CoV-2 virus during the COVID- 19 pandemic. 

theClubhou.se Labs Face Masks are intended for use by HCPs and the general to cover their noses and mouths, in accordance with recommendations of the US Centers for Disease Control and Prevention (CDC), to prevent the spread of SARS-CoV-2 during the COVID-19 pandemic.

theClubhou.se Labs Face Masks are authorized by the FDA under the EUA 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 Federal, Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

theClubhou.se Labs Face Mask have not been evaluated, cleared, approved, or authorized for:

• use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected;

• 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.