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Baylab USA, LLC manufactured and distributed surgical masks and respirators (ASTM Level 1 Mask, ASTM Level 3 Mask, and KN95 Respirator) intended for medical use without obtaining required FDA premarket approval (PMA) or investigational device exemption (IDE) authorizations, rendering these products adulterated under federal law. During a January 2024 inspection, FDA investigators determined that certain product versions lacked the necessary regulatory clearance despite being marketed for medical purposes including reducing exposure to particulates, bacteria, and blood or body fluids. The ASTM Level 3 Mask was additionally found to be misbranded for unapproved commercial distribution into interstate commerce.