MASKFONE does not and is not intended to provide antimicrobial, antibacterial, or antiviral protection to the wearer nor make any claims of particulate filtration or infection prevention or reduction. MASKFONE has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or any other governmental or administrative organization.
During the COVID-19 pandemic, the FDA has authorized the sale of face masks for use as personal protective equipment to help prevent the spread of infection or illness by the general public to help slow the spread of the virus under an emergency use authorization. MASKFONE is being marketed and sold under the terms of this emergency use authorization, and MASKFONE is currently authorized for marketing by the FDA only for as long as the public health emergency remains in effect.
MASKFONE is not a replacement for medical-grade protective equipment. Do not use MASKFONE in a clinical setting where the infection risk level through inhalation exposure is high.
MASKFONE is not intended for use as a surgical mask. Face masks do not provide liquid barrier protection and should not be used in any setting where significant exposure to liquid, bodily, or other hazardous fluids may be expected.
MASKFONE does not provide particulate filtration