On June 13, 2020, the manufacturer of fiber technologies Ascend Performance Materials, Houston, TX/USA, has submitted to the U.S. Food and Drug Administration a 510(k) premarket notification for clearance to market its Acteev technology in a pair of high-efficacy surgical masks to protect against SARS-CoV-2.
The masks, a nanofiber and a microfiber nonwovens version each branded under the Acteev Biodefend line for medical devices, deliver a one-two punch of antiviral properties plus top-level barrier protection against microbes, harmful airborne particles and fluid splatter.
Acteev technology has been shown in laboratory tests to deactivate SARS-CoV-2, the coronavirus that causes Covid-19, and other pathogens. The testing was conducted following the protocols of ISO, ASTM or other international standards organizations.
Ascend submitted its first 510(k) to the FDA last month. That submittal requests clearance to market a Level I surgical mask that is effective against SARS-CoV-2. Also last month, Ascend launched Acteev Protect, an antimicrobial line of protection specially formulated to guard against the growth of fungi, bacteria and other microbes to keep textiles and nonwovens fresher for longer. Acteev Protect, available for sale in the USA and select other jurisdictions, can beused to make face coverings, filtration devices, and textiles for upholstery and apparel such as activewear.