Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your website is offering for sale in the United States the KN95 Mask (which your website represents is manufactured by Dongguan Sengtor Plastics Products CO., LTD.) without marketing approval, clearance, or authorization from the FDA. Accordingly, these 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 3the 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 website contains false or misleading representations, including but not limited to: - Stating that the KN95 Masks are “CDC Approved & FDA Certified KN95 Mask…”, “FDA Approved & CDC Registered”, “FDA CE Certified”, “Appendix A: Authorized Imported, Non-NIOSH Approved Respirators” alongside images of and information about the KN95 Mask [https://www.databazaar.com/collections/kn95-respirator-masks]
Passage 4Unauthorized use of the FDA logo displayed alongside images of and information about the KN95 Mask [https://www.databazaar.com/collections/kn95-respirator-masks]