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Talk to a SpecialistTalk to a SpecialistCaptain's Cloth LLC was cited for marketing KN95 face masks as medical devices without FDA approval, clearance, or authorization. The company made disease prevention and treatment claims on its website and product packaging—including statements that the masks "filter out 95% of particles," "prevent virus," and "block droplets, body fluids, secretions"—which established the products as devices under federal law. These unapproved medical devices were offered for sale in the United States in violation of the Federal Food, Drug, and Cosmetic Act, rendering them adulterated.