Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistWorld Packaging Solutions, LLC was warned for selling the Purvigor KN95 Mask in the United States without FDA approval or authorization, making claims that the product provided "anti-infection," "anti-flu," and "anti-bacterial" protection with specific filtration efficiency ratings that established it as a medical device under federal law. The company failed to obtain either a Premarket Approval (PMA) or Investigational Device Exemption (IDE) before marketing the mask, rendering the product adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The mask was manufactured by Guangdong Fei Fan Mstar Technology Ltd. and marketed through the company's website without the required FDA notification and clearance.