ASCEND Performance Materials has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for clearance to market its Acteev technology for surgical masks to protect against the SARS-CoV-2 virus, which causes Covid-19.
The pair of masks, a nanofibre and a microfibre nonwoven version, are each branded under the Acteev Biodefend line for medical devices.
They have been designed to deliver antiviral properties while providing barrier protection against microbes, harmful airborne particles and fluid splatter.
Laboratory tests have proved that Acteev technology can deactivate SARS-CoV-2 and other pathogens such as betacoronavirus OC43, H1N1, human coronavirus 229E and Gram-positive and Gram-negative bacteria, including staphylococcus and E. Coli.
The masks achieve antiviral effectiveness through active zinc ions embedded within the polymer structure of polyamide 66, a hygroscopic nylon material whose equilibrium moisture keeps the zinc ions active.
Furthermore, they are said to meet the requirements to qualify as Level III under ASTM F2100-19 standards, as tested by independent laboratories and Ascend scientists.
According to the common international testing standard, Level III is the highest tier for physical barrier and safety properties.
Ascend noted that the technology has been tested in multiple end forms, including knit and woven fabrics, engineered plastics, and nanofibre meltblown.
The testing was conducted following the protocols of ISO, ASTM and other international standards organisations, the company said.
Ascend Performance Materials chief technology officer Vikram Gopal said: “Previous technologies rely on the materials within a mask to retain an electrical charge to achieve filtration efficiency. But when antimicrobial agents are added, those materials lose their charge and begin to fail as barriers.”
Ascend submitted its first 510(k) to the FDA last month to market a Level I surgical mask.