CULLMAN, Ala. – Cullman-based bedding manufacturer turned mask producer HomTex on Jan. 25 received authorization from the U.S. Food and Drug Administration (FDA) to distribute its Sovereign America line of surgical masks under the agency’s Aug. 5, 2020 Emergency Use Authorization (EUA) policy enacted to respond to equipment shortages resulting from the COVID-19 pandemic.
In a company memo, HomTex President/CFO Jeremy Wootten wrote, “This is a major development for us. We now have FDA approval for the Surgical 3 ply masks and are able to sell our Alabama made product to healthcare institutions, State agencies, Federal agencies, etc.”
The FDA said of masks approved under its EUA policy:
The FDA has made surgical masks available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by a Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of medical devices, including alternative devices used as medical devices, due to shortages during the COVID-19 pandemic.
This product has been authorized by FDA under an EUA for use by HCP (health care personnel) as PPE (personal protective equipment) in healthcare settings to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic. An authorized surgical mask made available under an EUA has not undergone the same type of review as an FDA-approved or cleared device. This product has not been FDA-cleared or approved. However, in the absence of an FDA-approved or cleared alternative and based on the totality of scientific evidence, it is reasonable to believe the authorized surgical mask may be effective for the authorized use. This product is 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, unless the authorization is terminated or revoked sooner. An FDA approved or cleared device should be used instead of the authorized surgical mask under EUA, when available.
According to the EUA, authorized surgical masks must meet certain criteria including:
- Fluid resistance
- Basic flame resistance
- Particle filtration
- Breathability
- Use of materials that are non-toxic, non-irritating and hypoallergenic
Wootten also announced that HomTex’s 3-ply masks have just passed a second round of FDA testing, and that the company is preparing to submit samples of its N95 masks, produced at its Selma plant, for approval as well.
Wootten concluded his memo, “Thank you so much to you all for your support and efforts on our behalf. We are excited about this breakthrough and what it means for our operations in Cullman and soon in Selma!”
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