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 FFP Level 2 and 3-ply Certified Masks FFP Level 2 without marketing approval, clearance, or authorization from the FDA.
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 3these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling is false or misleading. The devices are not FDA “Certified,” and so express statements to the contrary are false...
Passage 4Stating that the KN95 Mask FFP Level 2 and 3-ply Certified Masks are “FDA Certified” in the products’ descriptions
Passage 5Unauthorized use of the FDA logo***2*** displayed alongside images of and information about the KN95 Mask FFP Level 2 and 3-ply Certified Masks FFP Level 2
Passage 6Displaying the FDA logo on the N95 Mask FFP Level 2 packaging