Navigation Links
FDA Clears Single-Use Antibacterial Surgical Respirator

SILVER SPRING, Md., April 8, 2011 /PRNewswire-USNewswire/ -- 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.

For more information:

FDA Web page on Masks and N95 Respirators  

FDA's Role in Regulating Personal Protective Equipment  

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.

Media Inquiries: Amanda Sena, 301-796-0393,
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
9. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
10. FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
11. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni
Post Your Comments:
(Date:11/30/2015)... Asia,s largest exhibition and conference dedicated to the Medical Device ... 22 nd April 2016. --> --> ... --> -->   --> --> ... population and the government back up, the Medical Device is one of the ... . With the aging population and the government back up, the Medical ...
(Date:11/30/2015)... REDWOOD CITY, Calif. , Nov. 30, 2015 ... company that is providing innovative evidence-based solutions for the treatment ... Appeals Board (PTAB) at the U.S. Patent and Trademark Office ... (IPR) of U.S. Patent No. 8,359,102 (the ,102 patent).  ... 14, 2015, a unit of Boston Scientific Corporation filed two ...
(Date:11/30/2015)... ) has ... Market 2015-2019" report to their offering. ... of the "Orphan Drugs Market 2015-2019" ... and Markets ( ) has announced the ... report to their offering. ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... 30, 2015 , ... Trevor and Taylor Crabb have unveiled an exciting new ... to represent the United States. This hybrid crowdfunding campaign is designed to ... journey in addition to offering corporate sponsors with some great marketing deliverables with the ...
(Date:11/30/2015)... ... 2015 , ... The National Association of Professional Women (NAPW) honors ... Year Circle. She is recognized with this prestigious distinction for leadership in estate sales ... more than 850,000 members and over 200 operating Local Chapters. , “I’m pleased to ...
(Date:11/30/2015)... ... December 01, 2015 , ... Live Very Well is ... insurance plans on . The multi-carrier insurance exchange platform offers individual ... allowing consumers to compare, quote and match plans to meet their needs. ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... Foundation (Meso Foundation) released information for caregivers and held two webinars on topics ... available on demand free of charge at . , With a ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... is proud to announce that its ThermiRFR temperature controlled radiofrequency platform has received ... innovative multi-application radiofrequency platform which uses temperature as a clinical endpoint. The ...
Breaking Medicine News(10 mins):