REGULATORY AND LIABILITY NOTICE FOR MEDICAL USE
Our medical-grade shield (the “Face Shield”) is produced from UL94 rated polycarbonate and conforms to the U.S. Food and Drug Administration’s 21 CFR 177.1580 standard, however, the Face Shield has not been evaluated for the prevention of specific diseases or infections, the filtering of surgical smoke or plumes, the filtering of specific amounts of viruses or bacteria, or the killing or reduction of the amount of viruses, bacteria or fungi. Further, it is not to be used as a respiratory protective device, and therefore should not be used for particulate filtration.
The Face Shield (i) has not been cleared or approved by the U.S. Food and Drug Administration (“FDA”), (ii) has been authorized by FDA under an Emergency Use Authorization for use by health care personnel as personal protective equipment 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 COVID19 pandemic, and (iii) 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. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
By using this product, the end user assumes all risks associated with its use, including the voiding of manufacturers’ warranties of devices with which the product is used, and agrees to hold harmless and waive any claims against KlearStand, Inc., its affiliates, officers, employees and agents (collectively, the “Manufacturer”). Further, the end user is advised that, pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”), 42 U.S.C. § 247d-6d, the Manufacturer is a Covered Person and entitled to the protections arising under and the immunities conferred by the PREP Act. EXCEPT WHERE SPECIFICALLY PROHIBITED BY LAW, NO WARRANTIES OF ANY KIND ARE OFFERED FOR THE FACE SHIELD, INCLUDING WARRANTIES OF NON-INFRINGEMENT AND FITNESS FOR A PARTICULAR PURPOSE.
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