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Supply Chain

FDA Issues Emergency Use Authorization to HomTex for US-Made N-95 Masks

Image: StockMediaProduction/Adobe Stock woman with face mask in front of US flag
Every component of the mask is sourced and made in the United States, according to HomTex, which is poised to have the largest national production capacity for 100% made-in-America masks.

Alabama-based HomTex announced that it has received FDA Emergency Use Authorization for its Level 1 surgical masks, paving its entry into the US government and medical personal protective equipment (PPE) markets. HomTex currently manufactures 3-ply disposable masks and reusable cloth masks, which it supplies to the US Capitol. It soon will produce NIOSH N-95 masks at a new plant in Selma, AL, positioning HomTex as having the largest capacity in the United States to produce 100% made-in-America masks. The company operates facilities in Cullman and Mobile, AL; Tennessee; and North and South Carolina.

“When I say made in America, I mean every component is sourced in the US and made in the US,” said CEO Jerry Wooten in a prepared statement. “We believe that ramping up domestic manufacturing of PPE products is a national imperative from a safety, economic, and national security perspective, and HomTex is proud to meet that challenge.”

HomTex has the capacity to produce 700 million surgical 3-ply masks and 20 million NIOSH N-95 masks annually, said the company. It plans to open an additional manufacturing facility in Selma in the fall of 2021 that will create 300 jobs for the most economically disadvantaged region of Alabama.

Noting that some PPE made offshore, often in China, is defective or counterfeit, Wooten stresses the importance of “buying safe, genuine, and approved PPE from a trusted made-in-America manufacturer. We are proud to be a strategic provider to the Architect of the US Capitol, which supplies masks to the US House of Representatives, the US Capitol, and the US Senate,” he said. According to the Associated Press, federal law enforcement has seized 10 million counterfeit N95 masks alone, and the US Customs and Border Patrol announced in June 2020 that it seized 750,000 counterfeit face masks in 86 incidents, reports HomTex in its press release.

“We are immensely proud of all HomTex is doing to produce PPE,” said Katie Boyd Britt, President of the Business Council of Alabama. “Receiving this critical authorization from the FDA allows them to expand their PPE offerings and to keep Americans safe. We are thrilled to be a trusted partner as they expand their operations in Selma.”

A manufacturer of textile bedding products, HomTex manufactures DreamFit bedding and produces FDA-approved PPE masks. The certified Minority Business Enterprise has more than 400 employees.

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