May 12, 2016
SpectraShield™ 9500 Kills 99.99% of Tested Bacteria after One Hour and Inactivates 99.99% of Tested Influenza Viruses after Five Minutes of Contact
WAKEFIELD, Mass. – April 26, 2016 – For first responders and front-line healthcare workers, contracting airborne pathogens during pandemic or outbreak crises is a very real danger. Traditional infection-prevention strategies alone are no longer cutting it in an age where resistant strains are becoming far too common. To improve positive patient outcomes and better ensure the health of first responders, hospital workers and other medical professionals, the healthcare community is increasingly turning to antimicrobial-treated products to act as a second line of defense against some of the most common, and dangerous, strains of bacteria and viruses.
Respiratory masks have been a mainstay to block pathogens from entering airways but, before now, they have never been embedded with antimicrobials that could actually kill those pathogens. Sciessent, the leading provider of antimicrobial solutions, today announced that its antimicrobial technology was used in Nexera Medical’s SpectraShield™ 9500 Surgical Mask, the first product of its kind to be approved by the FDA for protection against bacteria and influenza viruses. The mask, which was approved for continuous use of up to eight hours, was proven to kill 99.99% of test bacteria after one hour of contact and inactivate 99.99% of test influenza viruses (seasonal, pandemic, avian, swine and equine) after five minutes of contact.
Sciessent’s silver- and copper-based antimicrobial technology is compounded into the mask’s polyester non-woven fibers from FOSS Manufacturing, which pursued the 510(k) submission on behalf of Nexera. When airborne pathogens come into contact with the surface of the SpectraShield 9500 Surgical Mask, the antimicrobial elements are activated, which eliminate microbe growth. An integral part of the Fosshield® fiber design, Sciessent’s antimicrobial technology is not a surface coating, which can wear off with use. Because the antimicrobial is only released when needed, the technology is designed for long-lasting performance of up to eight hours.
“Most respirators are designed to be occupational devices and are regulated by NIOSH and OSHA, but if a mask is declared for use in medical facilities, it falls under the jurisdiction of the FDA,” said James Morrell, CEO, Nexera. “Our SpectraShield 9500 Surgical Mask has proven to be safe for first responders and hospital workers and highly effective in killing airborne pathogens. In fact, it was cleared for eight hours of use, which is more than double the time required by NIOSH and OSHA. There is no other respiratory mask in the world cleared by the FDA to make those claims.”
Nexera is planning to file a special 510(k) submission with the FDA to remove the “surgical” indication from the device, which will broaden its use within consumer, government and non-profit organizations.
“While the use of antimicrobial technology has been commonplace with some medical devices for years, its use within other healthcare-related products, like respiratory masks, is becoming increasingly prevalent – particularly with concerns of influenza outbreaks that have occurred in recent years,” said Lise Moloney, director of business development, healthcare, Sciessent. “We are proud to provide the antimicrobial technology for the SpectraShield 9500 Surgical Mask, the only anti-bacterial and anti-viral surgical mask available that can aid in the protection of first responders, healthcare professionals and patients.”
About Sciessent LLC
Sciessent is a leading provider of customized antimicrobial solutions that enhance the value of customers’ products. Agion® antimicrobial solutions from Sciessent have been incorporated into a wide range of healthcare, industrial and consumer applications, including medical devices such as central-venous catheters and IV access ports, drinking-water applications like water filters and ice-making equipment, and textiles and apparel. The company’s brands include Agion, Agion Active and Sciessent Lava and are based on naturally occurring elements. Sciessent customers include leading international brands including Vygon, Medegen, Scotsman, Everpure, Follett, Honeywell, Adidas, Reebok and Skechers.
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 in the US; 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.