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Databazaar.com was selling KN95 masks through its website without FDA approval or clearance, marketing them with claims that they provided protection against COVID-19 and infectious agents. The masks were found to be adulterated because the company lacked an approved premarket approval (PMA) application or investigational device exemption (IDE), and misbranded because the firm failed to notify FDA of its intent to introduce the devices into commercial distribution as required under section 510(k). The FDA identified specific marketing language on the company's website representing the masks as providing ">95% filtration" for use "against the coronavirus" and by "healthcare professionals" against "infectious agents and viruses."