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Air Queen Offers 510K FDA Approved N95 Equivalent Mask in U.S.

Since the sudden onset of the COVID-19 pandemic the United States has faced a supply constraint of quality N95 masks. With the continued difficulty of being able to secure N95 designated products, health officials have been encouraging business and public consumers to find FDA certified “substantial equivalents,” such as the Air Queen mask to help address this shortage.

The term N95 basically means that a face mask will filter at least 95% of airborne particles and it is widely considered the gold standard of face coverings to protect individuals against harmful pathogens and other environmental contaminants. Traditionally used in the health care and industrial sectors the recent events related to the coronavirus outbreak have highlighted the need for a wider adoption of these extremely effective products to protect corporate workforces as well as individual families.

Air Queen, produced by TopTec a leading South Korean manufacturer, uses a highly advanced nano-fibre material to provide extreme protection (in excess of 96% particle filtration) while simultaneously allowing for advanced breathability and comfort. Furthermore, its advanced design is not structurally compromised by ethanol cleaning products and can be reused, a highly beneficial feature to reduce consumables costs. Compared to peer group manufacturers, such as 3M, the Air Queen is quantum leap in technology and effectiveness as well as filtration and air flow.

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 however, Independent research carried out by Nelson Labs confirms the company’s products provide particle protection and air flow far beyond the level afforded by N95 rated products. Wearers of nano-filter surgical masks, specifically Air Queen products, were found to have lower heart rates, lower micro-environment and skin surface temperatures than subjects who wore standard N95 masks while performing similar tasks.

In addition to the health and cost benefits, another key advantage of the Air Queen relates to its ability to distribute directly to the public. Air Queen’s FDA 510K approval has an over the counter (OTC) indication. AirQueen.US has begun selling its products to retail, and wholesale buyers including hospitals, state governments, labor unions, retail chains and e-commerce buyers. The Air Queen comes in both Adult and Child Sizes.

For more details on the quality of the Air Queen and how to access its benefits please see the details page of the website at airqueen.us.

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