Sciessent’s silver- and copper-based antimicrobial technology is compounded into the mask’s polyester nonwoven 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,” says 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,” says 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.”