Nexera Medical Receives European Union Clearance and CE Mark for the SpectraShield™ FFP2 RD and FFP3 RD REUSABLE Antimicrobial Respirator Mask – the first ever to receive this clearance
FORT LAUDERDALE, Florida (November 7, 2011)) – Nexera Medical, a leading developer of microbe-fighting textile-based healthcare products, receives EN 149: 2001 approval for its SpectraShield™ FFP3 RD and FFP2 RD Reusable Antimicrobial respirator masks from INSPEC International Ltd., a European Union certified testing facility located in Greater Manchester, United Kingdom. The tests were performed on the SpectraShield™ FFP3 RD and FFP2 RD in simulation of the practical use of the apparatus for reusability, including the initial "clogging test" using dolomite dust to emulate severe real-time conditions for a user. The dolomite testing method is exclusively used for measuring filtration performance for determining reusable efficiency. Both, the FFP2 RD and FFP3 RD masks met all of the filtration, inhalation, and exhalation requirements specific to each category of mask and met all the requirements for effective antimicrobial performance to earn both the reusable and antimicrobial classification for these masks. The "RD" after the FFP2 or FFP3 designates its reusability status earned by the "dolomite" testing method.
The SpectraShield™ mask begins to inactivate or kill certain strains of viruses and bacteria immediately on contact and continuously kills or inactivates over long periods of time. This revolutionary next generation mask is designed to give the general public, health officials, first responders, and care givers the best available protection against infectious diseases. The antimicrobial aspects were recognized by the test results received from the Health Protection Agency against bacteria on November 8, 2008 and from RetroScreen Virology Ltd. against viruses on January 22, 2009.
Considered as the next generation respirator masks, these are the first ever FFP2 RD or FFP3 RD masks to receive both a reusable and an antimicrobial designation, differentiating them from all other respirator masks in the market as they are reusable for periods of up to 14 days. These SpectraShield™ masks stand alone as the only reusable antimicrobially-protected respirator masks for the healthcare industry. Paul Sallarulo, President and Chief Executive Officer, stated; "Receiving this approval and CE Mark for the SpectraShield™ FFP2 RD and FFP3 RD continues our long-term objective of developing products designed to save lives and protect people in a widespread health crisis." Furthermore, he says; "We understand the need for governments and public health officials to have access to cutting edge technology that will help them prepare for and respond to future disease outbreaks and/or pandemics."
SpectraShield™ masks are manufactured using a patented technology of Fosshield® antimicrobial fibers used in the mask, which incorporate non-toxic silver-copper ionic agents that are proven safe and effective for extended contact with individuals. Due to SpectraShield™ antimicrobial properties, the SpectraShield™ FFP2 RD and FFP3 RD masks continuously self-sanitizes themselves for extended or repeat use.
The SpectraShield™ FFP2 RD and FFP3 RD will be marketed through independent medical product distributors throughout Europe and neighboring countries as the "GUARDIAN" model.
SpectraShield™ is a registered trademark of Nexera Medical, Inc.
# # #
Nexera Medical Inc. is headquartered in Fort Lauderdale, Florida. The company is engaged in the development, manufacturing, and distribution of antimicrobial respirator and surgical masks, as well as other planned antimicrobial textile based medical products such as medical slings, surgical site aprons and hospital linen products worldwide. All of Nexera's products are designed to provide maximum protection against microorganisms such as bacteria, virus, and fungus using Fosshield® patented technology. Nexera partners with governments and leaders in the health care industry in the fight against viral pandemic and other health care crises. To learn more, visit www.nexeramed.com.
Fosshield® fabric is manufactured by Foss Manufacturing, LLC (Foss®) based in Hampton, New Hampshire. Foss is a well-known leader and pioneer in the use of non-woven fabrics and specialty synthetic fibers in an ever-expanding number of environments and applications. Using new technologies and state-of-the-art computerized production, it is unrivaled in its ability to efficiently and effectively design, manufacture, convert, package, and distribute a vast array of specialty textile products worldwide. Foss is one of the world's largest needle-punch based manufacturers, and it has the expertise and experience to support customers' needs across virtually all applications and markets. To learn more, visit www.fossmfg.com.