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FDA-approved medical grade

The Air Queen masks we sell are FDA-approved N95 surgical-grade masks (classed as FFP2 respirators in Europe).

The product is functionally equivalent to 3M’s well-known 1805/1805S mask

The products are approved as Class II “Surgical Apparel” products, intended for use in operating theatre conditions, to protect patient and the wearer

The FDA registration details can be found here and the FDA’s letter confirming substantial equivalence to the 3M 1805/1805S can be accessed here

Independent laboratory tested

In March 2020 Nelson Labs conducted an aerosol test of the Air Queen masks

The test passes an aerosol of sodium chloride through the mask and measures the concentration of particles that penetrate the mask compared to the concentration entering the mask. The laboratory calculated the filtration performance and airflow resistance of the masks. Testing was performed in compliance with the US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.

The laboratory findings were:

  • Breathability. Air Queen inhalation resistance was found to be 8.9 to 10.2 (mm H2O) and exhalation resistance was found to be 9.1 to 9.7 (mm H2O). This compares to inhalation/exhalation resistance criteria specified in 42 CFR Part 184.180 of 35mm/25mm of water column height pressure. The masks therefore conform comfortably to these NIOSH criteria for airflow resistance.
  • Filtration. Air Queen filtration efficiency was found to be 94.4% to 98.3%. The masks therefore conform to N95 standards for filtration efficiency.

The laboratory’s report can be accessed here

Superior nanofibre performance

The Air Queen masks use a nanofibre filtration layer. Most cheap disposable masks feature either a simple cotton sheet, or a filtration layer made of melt-blown fibre. Melt blown fabric is a non-woven way of manufacturing polymer into continuous filaments in a random laid non-woven fabric. Melt blown fabric is common in diapers and feminine hygiene products, because of its high absorption. When used in face masks, the result is that the fabric quickly becomes moist after which its filtration effectiveness is reduced.

Air Queen out-performs N95/KF94

The comparison table shows a clear out-performance by the nanofibre mask, like Air Queen, especially on important metrics such as filter performance and inhalation / exhalation resistance (i.e. breathability)

ISO and European certifications