Fixture Display LLC

Selected passages from the FDA letter

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

Passage 1

The 3-ply Surgical Mask Disposable Face Mask (which your website represents is manufactured by Dongguan Weier Medical and Technology Co., Ltd.) is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA.

Passage 2

Accordingly, this product is 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

This product is 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***1*** and the 3-Ply Surgical Mask Disposable Face Mask are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false or misleading.

Passage 5

Displaying a “Certification of FDA Registration” issued by “UCL-REGSERVICE INC” (UCL-REGSERVICE Certificate) alongside KN95 Face Mask product information.

Passage 6

Displaying a “Certification of FDA Registration” issued by “Shenzhen CCT Testing Technology Co” (Shenzhen Certificate) alongside the 3-ply Surgical Mask Disposable Face Mask product information.

Passage 7

Statement alongside the 3-Ply Surgical Mask Disposable Face Mask that the product is “FDA Approved”

Passage 8

Statement that the KN95 Face Masks “are genuinly [sic] KN95 which meets all FDA requirements for medical and trade use”

Passage 9

The UCL-REGSERVICE Certificate bearing the FDA logo, positioned near images of and information about the KN95 Face Mask is misleading because it implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment

Passage 10

In addition, FDA has not approved the 3-Ply Surgical Mask Disposable Face Mask, so statements to the contrary are false.

Passage 11

Furthermore, display of the Shenzhen Certificate bearing the FDA logo positioned near images of and information about the 3-ply Surgical Mask Disposable Face Mask is misleading because it implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product(s) and/or establishment

Passage 12

Although the KN95 Face Mask and 3-ply Surgical Mask Disposable Face Mask Certificates contain legible language that appears to be intended to function as a disclaimer, including a statement that the Certificates do not denote FDA endorsement or approval, statements that FDA does not issue or recognize certificates of registration, and a statement that quotes 21 CFR 807.39, the small font size and overall placement of such language could be easily overlooked and does not limit or otherwise mitigate the misleading impression created by the use of the Certificates.