Speak Safe 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. Speak Safe 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. Speak Safe is being marketed and sold under the terms of this emergency use authorization, and Speak Safe is currently authorized for marketing by the FDA only for as long as the public health emergency remains in effect.
Speak Safe is not a replacement for medical-grade protective equipment. Do not use Speak Safe in a clinical setting where the infection risk level through inhalation exposure is high.
Speak Safe 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.
Speak Safe does not provide particulate filtration