This means that the Air QUEEN Nano Mask is "substantially equivalent" to a legally marketed device in the US, which in this case is the 3M VFlex 1805/1805S.  Furthermore, as a Class II surgical mask, the Air QUEEN Nano Mask is "Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material." 

 

Anyone can register their mask with the FDA.  However, most masks do not have the added FDA clearance as a surgical mask that the Air QUEEN Nano Mask has achieved.

Please note that the 3M VFlex 1805/1805S was replaced by the 1804S.

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