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maskshell.com was cited for selling unapproved medical devices—specifically KN95 masks, surgical masks, and children's protective masks—that were marketed for COVID-19 mitigation and prevention without FDA authorization. The company violated federal law by failing to obtain required premarket approval (PMA), investigational device exemption (IDE), or 510(k) clearance before distributing these products, rendering them adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. Additionally, the products were misbranded because the company did not provide the mandatory notice of intent to introduce the devices into commercial distribution as required under section 510(k).