FDA Grants Emergency Use Authorization for Proprietary Mask from HanesBrands

11/6/20

By Meredith Dockery, NC Biz News

The U.S. Food and Drug Administration issued an emergency use authorization for a proprietary mask developed by HanesBrands along with researchers from the University of North Carolina at Chapel Hill and North Carolina State University for use by health care providers as personal protective equipment, the apparel company announced on Thursday.

UNC Health tested the two-ply, single-use surgical masks to assure they meet FDA filtration standards and OSHA respiratory protection program requirements. N.C. State’s Nonwovens Institute designed the fabric, while UNC and N.C. State biomedical engineers and UNC Health infection prevention experts designed the fit.

The mask has a duckbill shape for better breathability and a wire nosepiece, a foam insert, and stretchable straps to create a better fit.

“We provided the Hanes mask to clinical areas concerned with protection during specific clinical encounters where N95 respirators are not recommended, but the risk of COVID-19 exposure is perceived to be high,” UNC Health Director of Infection Prevention at UNC Medical Center Dr. Emily Sickbert-Bennett, said in the release.

“The Hanes mask made these providers feel safe and well protected. I expect we will broaden the use of the Hanes mask given the degree of protection it provides,” Sickbert-Bennett added.

“We are delighted to have this mask added to the FDA’s Emergency Use Authorization for surgical masks during the COVID-19 pandemic,” HanesBrands’ Director of Research and Development Mike Abbott said in the release.

“It is a testament to the ingenuity and collaboration of our university partners and our R&D team to quickly develop a much-needed mask that is high quality, affordable and comfortable for health care professionals,” Abbott added.

HanesBrands (HBI), a maker of underwear and basics, last traded down 7 cents, or 0.53 percent, near $13.26 on Friday.

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