Description
Nanofiber Filter Mask
The Black Air Queen Nano 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.
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.
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
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