Dongguan City Xinyuan Nonwoven 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

representations that theDisposable Medical Face Mask is a “disposable protective mask” with “filtrationefficiency of > 90%” and “three layers of protection”

Passage 2

representations that the Wholesale Disposable Medical Protective CE Mask 3 Ply is“medical protective clothing ”intended to “isolate 99% of virus [and] protect you fromviruses,” has “3 ply construction to help filter up to 99% bacteria exhaled by the wearer,”and is “designed for general purpose infection control, and helps prevent the spread ofairborne illness”

Passage 3

representations that the 3 Ply Disposable Medical Filter Nonwoven Face Mask Dust is a “medical mask” intended to “isolate 99% of virus [and] protect you from viruses,” has “3 ply construction to help filter up to 99% bacteria exhaled by the wearer,” and is “designed for general purpose infection control, and helps prevent the spread of airborne illness”

Passage 4

The Disposable Medical Face Mask, Wholesale Disposable Medical Protective CE Mask 3 Ply, and 3 Ply Disposable Medical Filter Nonwoven Face Mask Dust are being offered for sale in the United States without marketing approval, clearance, or authorization from the FDA.

Passage 5

The 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 6

References to “…CE FDA dual certification…” in the product’s description

Passage 7

Displaying a “Certificate of FDA Facility Registration and Device Listing of Medical Device” issued by “HUMISS INC.” (HUMISS Certificate) under the “Company qualification” heading, “Product” tab on the product’s webpage. The HUMISS Certificate states that “Dongguan City Xinyuan Nonwoven Co., Ltd.…has completed the Facility Registration and Device Listing with the US FDA...” The HUMISS Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo***1*** and an illustration of an eagle.

Passage 8

Displaying a “Certificate of FDA Registration” issued by “Shenzhen STA Testing Co., Ltd.” (Shenzhen Certificate) under the “Company qualification” heading, “Product” tab on the product’s webpage. The Shenzhen Certificate certifies that “Dongguan City Xinyuan Nonwoven Co., Ltd” has “completed the with [sic] FDA Establishment Registration and Device Listing…” The Shenzhen Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo***1*** and an illustration of an eagle and a U.S. flag (or a similar flag).