Pairon Solutions LLC

Selected passages from the FDA letter

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

Passage 1

Statements made alongside an image of the Arun KN95 Folding Face Mask that it is “listed on FDA EUA for Non-NIOSH Devices” and representing compliance with “GB2626-2006”

Passage 2

Statements alongside an image of the Deming Surgical Mask that it provides “99% bacterial efficiency” and “complies ASTM F2100”.

Passage 3

Statements made on the packaging and alongside the images of the Pairon 3Ply Face Mask (Blue, White & Black) that they provide “>95% bacterial efficiency” and “helps filter out … bacteria”

Passage 4

Statements on your firm’s customer blog page representing that the BLUE – Pairon 3Ply Face Mask has been supplied to nursing home facilities

Passage 5

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 6

Representations that the Arun KN95 Folding Face Masks are “Certified: … FDA” and unauthorized display of what appears to be FDA’s logo***1*** on inner packaging of the product

Passage 7

Representations that the Deming Surgical Masks are “Certified: FDA” and unauthorized display of what appears to be FDA’s logo on packaging

Passage 8

Representations that Pairon 3Ply Face Masks (Blue, White & Black) are “FDA Registered”

Passage 9

Unauthorized display of what appears to be FDA’s logo alongside the BLACK – Pairon 3Ply Face Mask

Passage 10

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

Passage 11

Displaying a “Certification of Registration” issued by “Sungo Technical Services Inc.” (Sungo Technical Certificate) alongside Deming Surgical Mask product information.

Passage 12

Displaying a “Certification of Registration” issued by “Wayborn Quality & Technology Services” (Wayborn Certificate) alongside the BLUE – Pairon 3Ply Face Mask product information.