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
Lauren M. (verified owner) –
These masks were thinner than I thought when ordering. I expected them to be your typical KN95’s, and they just weren’t quite what I expected. The fit is a little weird as well, but I’d still prefer this over a regular cloth or surgical mask.
Simmons Medical Devices (store manager) –
Hi Lauren,
Thank you for your review!
However, I would have liked for you to contacted us before writing the review. The Air Queen Nano Mask is made with the Nano technology. As identified in the description on the website, the mask are paper thin but provide better protection than the kn95 mask. We recommend that every customer read the product description before making a purchase. This will alleviate numerous disappointments. Our Air Queen Nano Technology Mask is of great quality and offer excellent protection even being as thin as a sheet of paper. If you had contacted us before placing the review, I am certain that you would have given us a 5-star rating.
V/r,
Customer Service Dept.at Simmons Medical Devices