BEVERLY, Mass. — April 16, 2020 — Sciessent, a U.S.-based global provider of antimicrobial (AM) solutions based on controlled delivery, is working with a cooperative consortium of major apparel manufacturers that are dedicating production line capacity to meet the U.S. need for masks during the COVID-19 outbreak. Leading manufacturers within this consortium are incorporating Sciessent’s Agion® antimicrobial solution into masks designed for use in healthcare facilities. The Agion treatment incorporated into masks is modeled after the FDA, EU and Canadian cleared Nexera surgical respirator, that relies on Agion Antimicrobial performance to make FDA cleared claims to inactivate viruses by 99.99 percent in 5 minutes and kill 99.99 percent of bacteria in one hour.
Sciessent is providing chemistry to the consortium to produce 700 million face masks. The mills involved in U.S. production of the Agion-treated masks include long term partners of Sciessent and Parkdale Inc., American Apparel, Volunteer Knits, Beverly Knits, Sanmar and Carolina Cotton.
“We’re honored to be a part of this extraordinary effort to help meet the needs of this global challenge. Some models of Agion-treated masks are reusable and effective up to fifteen wash warm, tumble dry high cycles before discarding,” said Paul Ford, CEO, Sciessent. “The Sciessent team is committed to helping both healthcare device manufacturers and those from other sectors who are retooling to produce PPE, to get up and running with a proven effective, FDA cleared antimicrobial solution.”
Sciessent’s ability to partner with manufacturers through the FDA review process is key to those companies’ successful increase of their production of the types of masks currently in short supply during the global COVID-19 pandemic. The Sciessent Healthcare, Technical and Regulatory team effectively and quickly turns around answers to safety, efficacy and labeling questions posed by the FDA.
The Agion® Antimicrobial is presently registered by the United States Environmental Protection Agency as a preservative and bacteriostatic agent for use in treated articles under 40 CFR 152.25a. The information presented herein is not intended to support or endorse public health claims for treated articles. The Agion Antimicrobial is also used in medical devices under the Food and Drug Administration; those medical device claims are based on safety and efficacy testing and are limited to those approved by FDA. In the EU, the Agion Antimicrobial is used in medical devices under the Medical Device Directive: those medical device claims are based on safety and efficacy testing and are limited to those approved by the designated Competent Authorities and/or Notified Bodies.
Posted April 16, 2020