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FDA Approves Respirators for Use in Pandemic

N95 masks now used in industrial settings may help reduce exposure to airborne germs

WEDNESDAY, May 9 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval to the 3M Company of St. Paul, Minn., to market two air-filtering facepiece respirators for use in a public health emergency, such as pandemic influenza.

The respirators, which are N95 masks, can filter out up to 95 percent of small airborne particles and are currently widely used in industrial, health care and other workplace settings. The 3M Respirator 8612F and 8670F will be available without prescription.

The efficacy of the mask depends on the extent to which it is a good fit on the individual wearer. Industrial health and safety regulations require that respirators be individually fitted and tested for fit, but this would likely not be feasible in a public health emergency. 3M tested the masks that users self-fitted according to the instructions on the packaging and found that all participants gained protection but to varying degrees.

The FDA urges that respirators should be used in combination with a range of protective measures including hand hygiene, cough etiquette and avoiding crowded places. "We believe that minimizing exposure will help reduce risk," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health, in a statement. "These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals."

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