Nanofiber Filter Mask

Lighter than a sheet of paper, ergonomically designed for perfect fit and comfortability. The nanofiber filter provides strong protection with high filtration efficiency and breathability.

The Air Queen mask is a FDA 510k approved surgical respirator (K172500) with a use indication as follows, “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 materials.” Therefore, the mask provides the maximum protection while being used even in day-to-day activities. The Air Queen is not NIOSH approved because of its ear loop design.

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: 3M VFlex 1805/1805S (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