Notices & Disclaimer

* If your child has cardiac issues, or suffers from asthma or other respiratory conditions consult a doctor before using. If your child has difficulty breathing while wearing our “CHILDFACEMASK” product remove the mask immediately and discontinue further use until you have consulted a doctor. 

* Cloth face coverings should not be placed on young children under 2 years of age, or anyone who has trouble breathing, or is unconscious, incapacitated or otherwise unable to remove the mask without assistance.

The United States Center for Disease Control and Prevention (CDC) “recommends wearing cloth face coverings in public settings where other social distancing measures are difficult to maintain [for example, as to children: crowded playgrounds, childcare and day care facilities or schools and preschools] … Cloth face coverings may slow the spread of the virus and help
people who may have the virus and do not know it from transmitting it to others”.

* “The World Health Organization (WHO) advises that governments should encourage the use of non-medical fabric masks, which can act as a barrier to prevent the spread of the virus from the wearer to others where there are many cases of COVID-19, for people in the general public where physical distancing of at least 1 metre is not possible.”

* The “CHILDFACEMASK” product has been independently tested and certified to the standards of KN-90 – recommended by the CDC and other agencies for use by children]. and meets FFP2* [(95% protection standards) [*ECM Certified Compliance verified to Standard EN 149:2001 + A1:2009 related to CE Directive(s) R 2016/425 [Personal Protective Equipment] dated March 19, 2020 – copy available upon request].

* According to published scientific studies a EN 149:2001 + A1:2009 (FFP2-rated mask), such as our “CHILDFACEMASK”, can help to serve as protection against influenza viruses such as avian influenza or severe acute respiratory syndrome associated with the coronavirus (SARS), as well as, against the bacteria of pneumonic plague and tuberculosis. [See: “Risques infectieux en milieu de soins – masques médicaux ou appariels de protection respiratoire jetables : quell matérial choisir ?” sante.gouv.fr 27 August 2009. Retrieved 16 June 2015; and Technical Bulletin: Comparison of FFP2, KN-95, and N95 and Other Filtering Facepiece Respirator Classes” - 3M Personal Safety Division. January 2020].

* Despite the “CHILDFACEMASK” product’s proven level of safety testing and certification, this mask is recommended for non-medical use only and, notwithstanding public and government health regulatory agency announcements of its value, usefulness or efficacy during the pandemic, the “CHILDFACEMASK” product is not intended to diagnose, treat, cure, prevent or
mitigate any disease or illness.

* Except for use as a recognized source control device related to helping to prevent the spread of viruses, germs and harmful bacteria, the “CHILDFACEMASK” product is not a surgical mask; or intended to provide liquid barrier protection; or for use in a clinical setting where the infection risk level through inhalation exposure is high; or for antimicrobial or antiviral protection or related uses; or uses for infection prevention or reduction or related uses; or as a respiratory protective device; or for high risk aerosol generating procedures.

* The United States Food & Drug Administration (FDA) has concluded “… that the emergency use of face masks in accordance with CDC recommendations as source control … to help prevent spread of the virus during the COVID-19 pandemic meets the criteria for issuance of an [emergency use] authorization (EUA) under Section 564(c) of the [Food, Drug & Cosmetic] Act”. [https://www.fda.gov/media/137121/download]

* Statements regarding this product have not been reviewed or approved by the FDA and the product itself has not been FDA cleared or approved. This product is authorized 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 [Food, Drug & Cosmetic] Act, 21 U.S.C. § 360bbb-3(b)(1) unless the product is separately cleared or approved, or the authorization is terminated or revoked sooner.