Captain's Cloth LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Accordingly, this product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).

Passage 2

This product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 3

In addition, the KN95 Face Mask is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. Specifically, your websites contain false or misleading representations, including but not limited to: - Representations that the KN95 Face Masks “have an active status with the FDA…” [https://captainscloth.com/products/kn95-face-masks-5-pack] - Unauthorized display of what appears to be FDA’s logo***1*** on the front and back of the product’s labeling [https://captainscloth.com/products/kn95-face-masks-5-pack]