WINSTON-SALEM – A mask developed by HanesBrands along with researchers at N.C. State and UNC-Chapel Hill has received authorization from the US Food and Drug Administration for use by health care providers.

The company noted that the masks have not been FDA cleared or approved but authorized 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.”

Some of the masks are already being used by at UNC Medical Center.

“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 proprietary mask designed for use as personal protective equipment, or PPE, is two-ply, single use. It includes:

  • unique fabric developed by NC State’s Nonwovens Institute (nonwoven fabric is a fabric-like material made from staple fibre and long fibres, bonded together by chemical, mechanical, heat or solvent treatment notes Wikipedia.)
  • a fit design created in collaboration with UNC-Chapel Hill and NC State biomedical engineers and UNC Health infection prevention experts
  • comes in a duckbill shape for better breathability
  • includes a wire nosepiece and foam insert to enhance a contoured fit
  • 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 Mike Abbott, HanesBrands’ director of research and development, in a statement. “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.”

FDA authorization, not approval

However, Abbott told the Winston-Salem Journal that FDA authorization differs from FDA approval.

“Until we go through the FDA approval process, which is long and arduous, we can’t say that it can be used in a surgical setting,” Abbott said. Appropriate areas for use of the masks include “extended care and areas where a standard surgical mask is not allowed,” he added.

The FDA decision comes through 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,” HanesBrands said.

PPE has been a key issue in attempts to deal with the ongoing COVID-19 pandemic. Abbot said the company is focusing on healthcare providers for sales of the masks and added that they are not available to consumers.

The company noted that the masks have not been FDA cleared or approved but authorized 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.”

“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.

According to HanesBrands, the mask meets requirements for fluid resistance, flammability performance, particulate filtration, and breathability.

UNC Health, 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 were involed in testing that HanesBrands says “demonstrated the masks exceeded expected performance levels and has used the masks in targeted clinical settings.”