FDA Disclaimer

Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions

 

Kamanu Composites’ face shields are authorized by the FDA under an Emergency Use Authorization (EUA) for use by healthcare providers as personal protective equipment. This product is not FDA cleared or approved and is only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. The product is not intended for any use that would create an undue risk in light of the public health emergency. Face shields are considered by the FDA as providing “minimal or low barrier protection” and the use of the face shield alone will not prevent infection from microbes or viruses. Kamanu Composites face shields contain XLPE foam, Melinex PET film, and elastic cord, all of which can come in contact with the skin. The elastic cord contains a latex core, coated in silicone and wrapped in a polyester or nylon jacket.

Food and Drug Administration's Emergency Use Authorization