The company has submitted a 510(k) premarket notification to the regulator for clearance to the nanofiber and microfiber versions of the masks
Ascend Performance Materials is seeking clearance from the US Food and Drug Administration (FDA) for its Acteev technology in a pair of surgical masks to protect against SARS-CoV-2.
The company has submitted a 510(k) premarket notification to the regulator for clearance to the nanofiber and microfiber versions of the masks.
Each of the mask designs are branded under the Acteev Biodefend line for medical devices.
Ascend said that the masks are designed to deliver a one-two punch of antiviral properties plus barrier protection against microbes, harmful airborne particles and fluid splatter.
According to Ascend’s chief technology officer Vikram Gopal, laboratory tests of the company’s Acteev technology have demonstrated its ability to deactivate SARS-CoV-2, which causes COVID-19, and other pathogens.
The pathogens including H1N1, betacoronavirus OC43, human coronavirus 229E and Gram-positive and Gram-negative bacteria such as staphylococcus and E. coli.
Ascend said that the testing was carried out following the protocols of ISO, ASTM or other international standards organizations.
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.”
Acteev masks achieve antiviral effectiveness through active zinc ions
Through active zinc ions embedded within the polymer structure of polyamide 66, Acteev masks are said to obtain antiviral effectiveness.
Covered by more than 15 patent families, Acteev technology is said to have undergone testing in multiple end forms.
Gopal said: “With Acteev, we have cracked the code of balancing top physical performance with antiviral protection.”
In June, the company launched Acteev Protect, an antimicrobial line of protection specially formulated to guard against the growth of fungi, bacteria and other microbes for textiles and nonwoven fabrics.