HanesBrands Surgical Face Mask Receives Authorization by U.S. Food and Drug Administration

HanesBrands announces 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 receives authorization by the U.S. Food and Drug Administration for use by health care professionals as personal protective equipment (PPE).

The two-ply, single-use mask features fabric developed by NC State’s Nonwovens Institute combined with a fitted design created in collaboration with UNC-Chapel Hill and NC State biomedical engineers and UNC Health infection prevention experts.

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,” says 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 about the insufficient supply and availability of disposable single-use surgical masks that provide a physical barrier to fluids and respiratory droplets.

“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,” says 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, after meeting FDA requirements for fluid resistance (ASTM F1862), flammability performance, particulate filtration (ASTM F2100), and breathability (ASTM F2100).

“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,” explains 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.”

For more information on the masks and the authorization details, read the full release here.