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Talk to a SpecialistTalk to a SpecialistIrvin, Inc. marketed KN95 and disposable face masks as COVID-19 preventive devices on their website without FDA approval, clearance, or authorization, making the products adulterated under federal law. The company violated regulations by making disease claims including statements that the masks "protect from viruses," "prevent virus," and offer "COVID-19 protection" and "anti-droplet" capabilities, thereby establishing the products as medical devices requiring premarket approval or clearance. The masks were sourced from multiple Chinese manufacturers and sold directly to U.S. consumers without proper FDA oversight or documentation.