As of April 18, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the use of face masks for use by the general public, including health care personnel in healthcare settings as PPE to cover their noses and mouths, in accordance with CDC recommendations to prevent the spread of COVID-19 during the pandemic. Visit the CDC webpage for the most current recommendations on the use of face masks.
Intended Use: Members of the general public, including healthcare providers in healthcare settings as personal protective equipment, to cover their noses and mouths, in accordance with CDC recommendations, to prevent the spread of SARS-CoV-2 during the COVID-19 pandemic.
The product has not been FDA cleared or approved, is not considered a medical mask or device, is not to be used in high risk or surgical settings, and does not replace an N-95 or surgical mask. It does not provide liquid barrier protection where significant exposure to liquid, bodily or other hazardous fluids, may be expected.
The product has been authorized by FDA under an EUA for use by HCP as 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 virus during the COVID-19 pandemic
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 Act, 21 U.S.C. § 260bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
By purchasing this cover/mask, the buyer acknowledges that this product:
ADALÉI does not represent face covers/masks manufactured in our facility are safe or effective for the prevention or treatment of infection during the COVID-19 pandemic. We do not offer a warranty on the fabric of this product. If you have any problem with the construction of this face mask, please email details and pictures to info@adalei.com and we are happy to resolve any issues.
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, as of 4/18/20. Buyer recognizes that the FDA and CDC may change their guidelines for use of masks and is responsible for obtaining and distributing such changes and information.
Buyer agrees to make all of the foregoing information available to anyone receiving and/or wearing a cover/mask from this purchase. Buyer assumes all responsibility and risk for use of this cover/mask and will hold ADALÉI harmless and without liability in the use of this product.
Buyer is responsible for distributing an electronic or hard copy of this discloser to all individuals receiving a cover/mask from this purchase.
RETURN POLICY:
Due to the spread of the COVID-19 virus, we cannot offer returns or exchanges for our face masks.
FABRIC:
While Burlington fabrics are not designed to protect from viral or bacterial pathogens, they can be used for minimum and low performance category face masks.
SHIPPING:
Your order will be shipped to you using the carrier of your choice (USPS First Class Package, USPS 2nd Day Priority, or UPS Ground) and all orders will ship with delivery confirmation and can be tracked. ONLY USPS Priority and UPS Ground include insurance up to $100. We will provide this tracking information to you via email or you can choose to receive text (all applicable fees apply). We are not responsible for any packages that are lost in transit, stolen, damaged, or not received and in such event, recommend you contact the carrier for a resolution.