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Professional World Store was cited for marketing KN95 masks, 3-layer disposable surgical masks, and children's disposable masks as medical devices without obtaining required premarket approval. The company's websites made therapeutic claims including that products "block 95.99% of bacteria, dust, chemicals, particles, pollen and smoke" and "protect your children effectively against bacteria, dust, pollen, and pollution," establishing the products as devices intended to prevent disease under the Federal Food, Drug, and Cosmetic Act. These representations, combined with placement under a "Medical" tab on the company's website, constituted misbranding and failure to secure premarket approval before offering the devices for sale in the United States.