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Ascend's Newest FDA 510(k) Premarket Notification (PMN) Covers Nanofiber and Microfiber Applications
Houston – July 14, 2020 – Ascend announced that it has filed a 510(k) Premarket Notification (PMN) with the U.
This series of masks belongs to the ActeevBiodefend™ medical product series, including two non-woven versions of nanofiber and microfiber, reaching the highest protection level of 510(k), effectively killing viruses, and resisting the spread of microorganisms, aerosols, liquid splashes, etc.
Ascend Chief Technology Officer Dr.
This series of masks has been tested by an independent laboratory and a team of Ascend scientists and certified to meet the level III protection level under the ASTM F2100-19 standard
Dr.
Some masks achieve filtration and barrier effects through electrostatic adsorption of materials, and when antimicrobial agents are added, these materials will lose their charge and the protection will fail
The Acteev™ technology achieves antiviral effect by embedding active zinc ions in the PA66 polymer matrix
"Acteev™ is the code that balances physical barrier properties with antiviral properties for superior protection
Acteev™ technology covers more than 15 patent families and has been tested in a variety of finished product formats, including knitted and woven fabrics, engineering plastics, as well as nanofiber, meltblown and spunbond nonwoven materials
Ascend submitted its first 510(k) product listing application to the FDA last month, a Class I medical surgical mask based on Acteev™ technology that provides effective protection against SARS-CoV-2
Ascend also launched Acteev Protect™ antimicrobial fiber technology last month, a breakthrough technology designed to inhibit the growth of mold, fungus and other microorganisms, enabling long-lasting, safe, antibacterial and cleaning of textiles and nonwovens
About Acteev TM
About Acteev TM TMTests have proved that it can effectively kill viruses, bacteria and fungi with an efficacy of more than 99%
EPA compliant zinc ion intercalation polymer
Hygroscopic PA66 fabric absorbs moisture which activates zinc ions
Non-topical treatment or coating
Does not depend on silver or copper
Tests have proved that it can effectively kill viruses, bacteria and fungi with an efficacy of more than 99%
Tests have proved that it can effectively kill viruses, bacteria and fungi with an efficacy of more than 99%
EPA compliant zinc ion intercalation polymer
EPA compliant zinc ion intercalation polymer
Hygroscopic PA66 fabric absorbs moisture which activates zinc ions
Hygroscopic PA66 fabric absorbs moisture which activates zinc ions
Non-topical treatment or coating
Non-topical treatment or coating
Does not depend on silver or copper
Does not depend on silver or copper
Works great in a variety of finished forms:
◦ Knitted and woven fabrics for consumer textiles , home , workwear , masks , etc.
Knitted and woven fabrics for consumer textiles , home , workwear , masks and more
◦ Nanofiber , meltblown and spunbond nonwoven materials for filtration
Nanofiber , Meltblown and Spunbond Nonwoven Materials for Filtration◦ Fibers for carpets _
fiber for carpet _◦Engineering plastics for high-frequency contact surfaces
Engineering Plastics for High-Frequency Contact SurfacesDisclaimer: Laboratory tests have proven that Acteev™ technology can kill SARS-CoV-2 (the coronavirus that causes COVID-19) as well as other pathogens, including H1N1, 229E coronavirus, and Gram-positive and Gram-negative bacteria (eg: Staphylococcus and Escherichia coli)