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Talk to a SpecialistTalk to a SpecialistFixture Display LLC sold KN95 face masks and 3-ply surgical masks through its website without FDA marketing approval or clearance, making these products adulterated devices under federal law. The company's website made medical claims about the products, including statements that the KN95 masks "meet all FDA requirements for medical and trade use" and used the term "surgical" in product naming, establishing the masks as medical devices intended for disease prevention or treatment. The 3-ply surgical masks lacked required premarket approval (PMA) or investigational device exemption (IDE) authorization, representing a direct violation of FDA regulations for Class II/III medical devices.