Manhattan Stitching Company, Inc.

Selected passages from the FDA letter

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

Passage 1

FDA’s review of your websites revealed the following statements that establish that the KN95 Face Mask, 3-ply Face Mask, and 3-Ply Disposable Youth Face Mask are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to: • “Suitable for respiratory protection, filtering dust, haze, bacteria, droplets and other harmful particles in the air…The US Centers for Disease Control (CDC) now recommends that all Americans wear a fabric face mask outside their homes. We are not taking returns due to the Covid-19.”

Passage 2

your websites are offering for sale in the United States, the KN95 Face Mask (which your website indicates is manufactured by JinJiang Rongxin Maternal and Child Supplies Co., Ltd.), 3-ply Face Mask, and 3-ply Disposable Youth Face Mask without marketing approval, clearance, or authorization from 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 3

These 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 4

In addition, the KN95 Face Mask is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to a firm’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the devices are misleading and constitute misbranding. See 21 CFR 807.39.

Passage 5

Your website contains a false or misleading representation, including but not limited to: • Displaying a “Certificate of Registration” (Certification) issued by “Shenzhen Huawin Testing Certification Co., Ltd.” alongside KN95 Face Mask product information. The Certification states that “JinJiang Rongxin Maternal and Child Supplies Co., [Ltd.]…Has Completed With The U.S. Food and Drug Administration…Establishment Registration and Device Listing.” and incorporates unauthorized use of the FDA logo and an illustration of an eagle and a U.S. flag (or a similar flag).