Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The KN95 Specialised Face Mask, 3-Layer Disposable Surgical Masks, and 3-Layer Disposable Masks for Kids are offered for sale in the United States without marketing approval, clearance, or authorization fromthe FDA. Accordingly, the products are 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 2These products are 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 3In addition, the KN95 Specialised Face Mask and 3-Layer Disposable Surgical Masks are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading. Specifically, your websites contain a number of false or misleading representations, including but not limited to:
Passage 4“Our KN95 mask is FDA approved (Certificate no. BTK20200210001FDA) and has been certified to be effective and preventative in its use.” A “Certificate of Conformity” (Certificate) is positioned underneath this statement. Although much of the text found on the Certificate is illegible, the Certificate has the overall look of an official government document, incorporating unauthorized use of the FDA logo.***1***
Passage 5Unauthorized use of the FDA logo displayed alongside images of and information about the KN95 Specialised Face Mask
Passage 6Unauthorized use of the FDA logo displayed alongside images of and information about the 3-Layer Disposable Surgical Masks