Ascend Performance Materials has announced it has submitted its first FDA 510(k) for clearance to market its patent-pending Acteev technology in the United States in a medical device, a surgical mask under a new brand called Acteev Biodefend. Independent laboratory testing has found Acteev materials to achieve greater than 99% efficacy at deactivating bacteria, fungi, and viruses, including SARS-CoV-2, the company reports.
This mask is a nonwoven version of a nanofibre and a microfibre. Every mask patented 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. According to the Ascends chief technology officer, Vikram Gopal this technology has been shown in laboratory tests to deactivate SARS-CoV-2, the coronavirus that causes COVID-19, and other pathogens including H1N1, beta coronavirus OC43, human corona-virus 229E and Gram-positive and Gram-negative bacteria such as staphylococcus and E. coli. Testing for the protocols is conducted by ISO, ASTM, or other international standards organizations.
The proposed masks are also said to meet the necessities to qualify as Level III under ASTM F2100-19 standards, as tested by independent laboratories as well as Ascend scientists. Level III is the highest tier for physical barrier and safety properties, according to the common international testing standard. Dr. Gopal said the combination of superior physical properties and antiviral protection is a breakthrough in medical device technology, as many masks succeed either at antiviral protection or at filtration and barrier effectiveness but not at both.
Acteev technology is covered by more than 15 patent families, embeds active zinc, ions into the matrix of a specialty polymer. The unique point about this Acteev material is the coupling between the antimicrobial ingredient like zinc and the specialty polymer that keeps the zinc ions active and bound at all times.
“Previous technologies rely on the materials within a mask to retain an electrical charge to achieve filtration efficiency,” Dr. Gopal said. “But when antimicrobial agents are added, those materials lose their charge and begin to fail as barriers.”
“Acteev masks, however, 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.” With Acteev, they have cracked the code of balancing top physical performance with antiviral protection. The technology, covered by more than 15 patent families, has been tested in multiple end forms, including knit and woven fabrics; engineered plastics; and nano-fiber meltblown, microfiber meltblown and spunbond non-woven materials.
In the last couple of months, 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 nonwoven fabrics fresher for longer. Acteev Protect, available for sale today in the United States and select other jurisdictions, can be used to make face coverings, filtration devices, and textiles for upholstery and apparel such as active wear.
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