Zhejiang Xichen Medical Technology Co., Ltd.

Selected passages from the FDA letter

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

Passage 1

The FFP2 NR 5-Layer KN95 Face Mask, Medical Face Mask, and Sterile Surgical Mask (each of which your website indicates is manufactured by Zhejiang Xichen Medical Technology Co. Ltd) are offered for sale in the United States without marketing approval, clearance, or authorization from the 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 2

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 3

In addition, the FFP2 NR 5-Layer 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. 21 CFR 807.39.

Passage 4

Displaying a “FDA REGISTRATION CERTIFICATE” also referred to as the “kn95-FDA Certificate” issued by “J & F Technology Services LLC” (Certificate) under the “About Us” tab on your website. The Certificate certifies that “Zhejiang Xichen Medical Technology Co., Ltd…has completed the FDA Establishment Registration (as manufacturer, foreign exporter, contract manufacturer) and Device Listing with the US Food & Drug Administration.” The Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo***2*** and an illustration of an eagle and a U.S. flag (or a similar flag).

Passage 5

Displaying a screenshot titled “kn-95-Registration information is available on the FDA website” of what appears to be Zhejiang Xichen Medical Technology Co., Ltd.’s previous entry in FDA’s Establishment Registration & Device Listing Database.

Passage 6

Taken together, display of the Certificate, bearing the FDA logo, and a screenshot from FDA’s Establishment Registration & Device Listing Database positioned near images of and information about the FFP2 NR 5-Layer KN95 Face Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Zhejiang Xichen Medical Technology Co., Ltd. is or was registered with the FDA and that the firm is or was in possession of a registration number.

Passage 7

We also note that you seem to reference the Certificate or some other certificate on the Sterile Surgical Mask’s webpage [https://www.xichen-med.com/mask/sterilesurgical-mask.html], indicating the product has a “Certificate CE, FDA.”