The two filtering facepiece respirators to be made by the 3M Company based in in St. Paul, MN, will be available to the general public without the need for a prescription.
The devices are called the 3M Respirator 8612F and 3M Respirator 8670F and are also certified and approved for respiratory protection by the National Institute for Occupational Safety and Health.
"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, M.D., director of the FDA's Center for Devices and Radiological Health.
"These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals during such events," add Dr. Schultz.
These respirators are meant to fit snugly over the face and are designed to filter out at least 95 percent of even the smallest airborne particles.
These devices are designed for adults and most likely will not fit properly on children. Testing for proper fit is imperative to successful filtration. Even hairs can interfere with the filtration effects of the device.
The FDA plans to issue a "guidance document outlining its regulatory approach" to the new device.
The FDA warns that anyone suffering from heart or lung disease may have a hard time breathing through a respirator.
