ADVISORY FOR VISITORS IN THE UNITED STATES
US Government Notice Concerning Product Claims About COVID-19
The Stay Safer PRN95+ Protective Face Mask is neither a CDC/NIOSH Certified N95 Respirator nor an FDA-approved Class II Surgical Mask. It is a non-medical face mask authorized for use by the FDA under an Emergency Use Authorization (EUA) by health care employees (HCEs) 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 community spread during the COVID-19 pandemic. This face mask is not intended to be construed as being a medical device or for use as PPE by HCEs in clinical settings when the use of a medical device or traditional PPE, to provide wearer or patient protection, is required.
Please note that without specific EPA or FDA approval, claims cannot be made about any antimicrobial agent’s protection or prevention against specific organisms infectious to humans or that of any fabric treated with the agent. As such, while this face mask does not cause damages to, nor bring additional risks for, wearers according to its intended use, it cannot be stated that it can prevent or protect from any form of risks to a person's health or safety, illness or disease (or otherwise). Research, studies, and data provided in support of the science and technology behind our mask — while truthful, accurate and complete — is presented for informational and educational purposes only. For a detailed discussion of this topic, see below. Otherwise, acknowledge your understanding of the aforementioned by clicking the button above to proceed on to learn more about our innovative face mask.
United States Federal Government Oversight
Some face mask manufacturers continue to make false, misleading and deceptive claims about the efficacy and safety of their products, antimicrobial agents, etc. As such, the US Food and Drug Administration (FDA) recently imposed severe limitations on claims that can be made about face masks, antimicrobials, etc. Likewise, the US Environmental Protection Agency (EPA) has strict rules regarding marketing claims made about antimicrobial capabilities, especially as it regards their effectiveness against COVID-19. While we appreciate the sheer volume of product claims made, the amount of oversight required, and that even federal agencies have finite resources; and while these restrictions may be needed under the situation, the unintended consequence is that informed consumers are deprived of learning about new innovations…and new innovations is stifled.
Restrictions and Requirements
Cloth face masks had not been regulated when they were intended solely as source control to curb viral spread in non-medical settings. Due to their more widespread use, that changed. Now, without specific EPA or FDA approval, claims cannot be made about an antimicrobial’s protection or prevention against specific organisms infectious to humans or that of the treated fabric. Unless authorized by the EPA or FDA, any face mask's claim as to the antimicrobial’s capability must be limited to the face mask itself; be specific and not unqualified; not reference health-related microbes, and; refrain from denoting personal (e.g., “for skin, wound, respiratory”) protection (very limiting factors: re describing a face mask with two redundant antimicrobials).
Many claims are made about antimicrobials their "perceived" effectiveness against COVID-19. As of September 2020, no organization can justly make a claim about and product’s effectiveness against COVID-19. To be clear, there has been no approval, for any form of government-sanctioned testing performed in the US or elsewhere, to prove the effectiveness of any antimicrobial agent against COVID-19. Further, while an active antimicrobial biocide may be effective against a virus in its pure state, it may not have proven antiviral properties when it is built into fabrics and masks.
Emergency Use Authorization (EUA)
While the Stay Safer PRN95+ Protective Face Mask has not been FDA cleared it is authorized by the FDA for use by Health Care Personnel (HCP) as Personal Protective Equipment (PPE) to help curb the spread of infection/illness in healthcare settings under an Emergency Use Authorization (EUA), here, and by the general public to help slow COVID-19 spread. The Stay Safer mask is authorized only for the duration of the declaration that circum-stances exist justifying the authorization of the EUA of medical devices, including alternative products used as medical devices, during the COVID-19.
Provided for Educational Purposes Only
Claims made by the Research Consortium, as to the efficacy, safety and eco-impact of triboelectric air filters and certain chemical antimicrobials, beyond those described above, are not approved by the FDA. We believe the public should have access to accurate, up-to-date research and information and, for educational purposes, we are making available the Research Consortium’s 75-page study – COVID-19, Its Transmission and Face Mask Efficacy – and other research on the efficacy of triboelectric air filters and QAC-based chemical antimicrobials against gram-negative, encapsulated microbes and their history of being safe and ecofriendly. We also share various laboratory tests re: particle filtration, viral deactivation and bioburden build-up inhibition.
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