US FDA REGULATORY DETAILS Nanofiber Filter Mfr: Lemon Co, LTD (Korea) Mask Manufacturer: TOPTEC Co, LTD (Korea) Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX 510(k) Registration No: K172500 Trade/Device Name: Technoweb Surgical Mask Common Name: Surgical Respirator Predicate Device: (N95) IFU: Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganism, body fluids and particulate material Other: CE FFP2 NR Approved for Sale EU CE-Mark, European SGS, REACH, RoHS