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HanesBrands Proprietary Surgical Face Mask Receives Authorization by U.S. Food and Drug Administration
HanesBrands Proprietary Surgical Face Mask Receives Authorization by U.S. Food and Drug Administration
November 5, 2020 at 10:35 AM EST
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The two-ply, single-use surgical mask features a unique fabric developed by NC State’s
The Hanes mask uses a duckbill shape for better breathability, a wire nosepiece and foam insert to enhance a contoured fit, and placement of stretchable straps for a secure fit.
“We are delighted to have this mask added to the FDA’s Emergency Use Authorization for surgical masks during the COVID-19 pandemic,” said
The FDA issued its Emergency Use Authorization for surgical masks in response to concerns relating to the insufficient supply and availability of disposable single-use surgical masks that provide a physical barrier to fluids and respiratory droplets.
The use of unique spun-bond fabric developed by the
“The Nonwovens Institute is proud to be a part of this collaboration to ensure that high-quality and affordable protective gear remains available to frontline health care workers during the pandemic,” said Dr. Behnam Pourdeyhimi, executive director of the
The Hanes mask was added to the FDA Emergency Use Authorization on
UNC Health’s testing, supported by the
“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,” said UNC Health’s Dr.
The company is selling the surgical masks to health care organizations for use by professionals in health care settings. Separately, the company is selling all-cotton and polyester blend face masks for consumers under its Hanes and Champion brands that are available online, in leading retail stores and in company outlet stores.
In accordance with the FDA surgical mask Emergency Use Authorization, HanesBrands’ disposable, single-use surgical masks:
- Have not been FDA cleared or approved.
- Have been authorized by FDA under an EUA for use in health care settings by health care personnel to provide a physical barrier to fluids and particulate materials to prevent health care personnel exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.
- Are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. Section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
In accordance with the FDA face coverings Emergency Use Authorization, HanesBrands’ government cloth face coverings and consumer face masks:
- Have not been FDA cleared or approved.
- Have been authorized by the FDA under an EUA for use by health care professionals as personal protective equipment to help prevent the spread of infection or illness in health care settings and by the general public to help slow the spread of the virus during the COVID-19 pandemic.
- Are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. Section 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
HanesBrands
HanesBrands, based in
View source version on businesswire.com: https://www.businesswire.com/news/home/20201105005771/en/
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