HanesBrands (NYSE:HBI) today announced that a proprietary
surgical face mask developed in conjunction with North Carolina
State University, the University of North Carolina at Chapel Hill
and UNC Health has been authorized by the U.S. Food and Drug
Administration for use by health care professionals as personal
protective equipment.
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Mike Abbott, director of research and
development for HanesBrands, credits the collaboration between the
company and its university partners for the quick development of a
much-needed mask for health care professionals. (Photo: Business
Wire)
The two-ply, single-use surgical mask features a unique fabric
developed by NC State’s Nonwovens Institute combined with a fit
design created in collaboration with UNC-Chapel Hill and NC State
biomedical engineers and UNC Health infection prevention
experts.
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. UNC Health tested
the masks to assure they meet FDA particulate filtration standards
and OSHA respiratory protection program requirements.
“We are delighted to have this mask added to the FDA’s Emergency
Use Authorization for surgical masks during the COVID-19 pandemic,”
said Mike Abbott, HanesBrands’ director of research and
development. “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.”
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 Nonwovens
Institute, the world’s first accredited academic program for the
field of engineered fabrics, eliminates the need for a third
filtration layer for cost efficiency and filtering effectiveness.
The spun-bond fabric is composed of two different polymer materials
to make a single fiber that has significant strength and bulk that
is as effective in filtration as current materials on the
market.
“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
Nonwovens Institute at NC State.
The Hanes mask was added to the FDA Emergency Use Authorization
on Oct. 5, 2020, after meeting FDA requirements for fluid
resistance (ASTM F1862), flammability performance, particulate
filtration (ASTM F2100), and breathability (ASTM F2100).
UNC Health’s testing, supported by the UNC School of Medicine
Center for Environmental Medicine, Asthma, and Lung Biology and the
U.S. Environmental Protection Agency Human Studies Facility in
Chapel Hill, demonstrated the masks exceeded expected performance
levels and has used the masks in targeted clinical settings.
“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. Emily
Sickbert-Bennett, director of infection prevention at UNC Medical
Center in Chapel Hill. “The Hanes mask made these providers feel
safe and well protected. I expect we will broaden use of the Hanes
mask given the degree of protection it provides.”
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.
The U.S. Centers for Disease Control and Prevention recommends
the wearing of cloth face coverings to help prevent the spread of
COVID-19, especially when social distancing cannot be practiced.
Emerging evidence indicates face coverings act as barriers to the
dispersion of respiratory droplets when worn over the mouth and
nose.
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 Winston-Salem, N.C., is a socially responsible leading
marketer of everyday basic innerwear and activewear apparel in the
Americas, Europe, Australia and Asia-Pacific. The company sells its
products under some of the world’s strongest apparel brands,
including Hanes, Champion, Bonds, DIM, Maidenform, Bali, Playtex,
Lovable, Bras N Things, Nur Die/Nur Der, Alternative, L’eggs,
JMS/Just My Size, Wonderbra, Berlei, and Gear for Sports. The
company sells T-shirts, bras, panties, shapewear, underwear, socks,
hosiery, and activewear produced in the company’s low-cost global
supply chain. A Fortune 500 company and member of the S&P 500
stock index (NYSE: HBI), Hanes has approximately 63,000 employees
in more than 40 countries. For more information, visit the
company’s corporate website at www.Hanes.com/corporate and newsroom
at https://newsroom.hanesbrands.com/. Connect with the company via
social media: Twitter (@hanesbrands), Facebook
(www.facebook.com/hanesbrandsinc), Instagram (@hanesbrands), and
LinkedIn (@Hanesbrandsinc).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105005771/en/
News Media: Carole Crosslin, (336) 671-3704,
carole.crosslin@hanes.com Analysts and Investors: T.C. Robillard,
(336) 519-2115
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