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FDA NEWS RELEASE

For Immediate Release: April 8, 2011
Media Inquiries: Amanda Sena, 301-796-0393, amanda.sena@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
 
FDA clears single-use antibacterial surgical respirator
New product protects against infection from microorganism, body fluids, other material
 
The U.S. Food and Drug Administration cleared the SpectraShield 9500 N95 surgical respirator, a device that kills 99.99 percent of three different kinds of bacteria when exposed to its outer surface.
 
The FDA cleared the SpectraShield as a single-use, N95 surgical respirator for use in health care settings by health care personnel to protect against microorganisms, body fluids and particulate material.
 
Data from laboratory tests demonstrated that the respirator is effective against the following bacteria: Streptococcus pyogenes, Methicillin-resistant Staphylococcus aureus, also called MRSA, and Haemophilus influenzae.
 
"The SpectraShield 9500 N95 anti-bacterial surgical respirator may reduce the risk of exposure to specific bacterial agents during medical emergencies," said Elizabeth Claverie-Williams, branch chief of Infection Control Devices at the FDA’s Center for Devices and Radiological Health.
 
N95 surgical respirators are different than regular facemasks, which are designed to help block large-particle droplets, splashes, sprays, or splatter that may contain viruses and bacteria from reaching the mouth and nose.
 
While a regular facemask may be effective in blocking splashes and large-particle droplets, it does not filter or block tiny particles that may be transmitted by coughs, sneezes, or certain medical procedures. Regular facemasks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface and the face.
 
The N95 designation means that the respirator blocks at least 95 percent of very small particles when subjected to careful testing. If properly fitted, the capabilities of N95 respirators exceed those of regular facemasks. Even a properly fitted N95 respirator, however, does not eliminate the risk of infection, illness, or death.

N95 surgical respirators cleared by the FDA for use in health care settings, including the SpectraShield 9500 N95 surgical respirator, have also been evaluated by the National Institute for Occupational Safety and Health, part of the Centers for Disease Control and Prevention.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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