NMI Health, Inc. (fka NANM)

[beigledog]

FDA Clears 3M Emergency Respirators
Wednesday May 9, 10:48 am ET
FDA Gives 3M Approval to Market First Respirators for Use in a Health Emergency


WASHINGTON (AP) -- Government regulators have granted 3M Co. approval to market the first respirators for use in a public health emergency, such as a flu epidemic.
While many companies make respirators for use in the workplace, including health-care settings, the Food and Drug Administration said Tuesday that two models from 3M are the first respirators targeted at the general public in the event of a medical emergency.

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The 3M respirators are essentially the same as a variety already approved by the National Institute for Occupational Safety and Health, which certifies the effectiveness of work-related equipment. FDA is requiring all companies who want to market respirators for use in public health emergencies to have them certified by the institute.

Shaped like a face mask, the respirators fit tightly over the nose and mouth and are designed to stop at least 95 percent of very small airborne particles.

"While the exact nature and concentration of the biological agent or germ may not be known in a public health medical emergency, we believe that minimizing exposure will help reduce risk," said Daniel Schultz, who heads FDA's device center.

Calls placed to the company seeking more information were not immediately returned.