FDA WARNING_LETTER - Pairon Solutions LLC - July 14, 2021

On August 9, 2021, the FDA issued a Warning Letter to Pairon Solutions PPE, following a July 14, 2021, review of their website, https://www.paironsolutionsppe.com/. The FDA determined that the "Arun KN95 Folding Face Mask," "Deming Surgical Mask," and "Pairon 3Ply Face Mask" (Blue, White & Black) are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), due to their intended use for disease mitigation, prevention, treatment, diagnosis, or cure.

The products are deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because the firm lacks premarket approval (PMA) or an investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the FDA of intent to introduce devices into commercial distribution as required by section 510(k), 21 U.S.C. § 360(k). Furthermore, the products are misbranded