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BMHshop was cited for selling KN95 masks, surgical masks, and children's masks with claims that they prevented, mitigated, or treated COVID-19, thereby classifying them as unapproved medical devices under federal law. The company made specific disease-prevention claims on its website, including representations such as "Anti-COVID-19," "Effective prevention of COVID-19," and "ANTI-VIRUS," which violated FDA requirements for uncleared devices. These products were adulterated and misbranded because they lacked the required FDA clearance or authorization to make COVID-19-related health claims.