These two filtering facepiece respirators, manufactured by St. Paul,
Minn.-based 3M Company (and called the 3M Respirator 8612F and
8670F), will be available to the general public without a
The devices are also certified as N95 filtering facepiece
respirators by the National Institute for Occupational Safety and
Health (NIOSH). NIOSH certifies respirators for use in occupational
settings in accordance with an appropriate respiratory protection
An N95 filtering facepiece respirator is a type of face mask that
fits tightly over the nose and mouth. It is made of fibrous material
that is designed to filter out at least 95 percent of very small
airborne particles. The filter and a proper fit determine the
effectiveness of the product.
"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, 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."
Many companies make N95 respirators for workplaces, including
health care settings. However, the 3M respirators are the first
devices to receive FDA clearance for use by the public during public
health medical emergencies to reduce exposure to airborne germs.
Under Occupational Safety and Health Administration and other
occupational health regulations, respirators used in the workplace
must be individually selected for each worker and tested to ensure a
proper fit. This kind of fit testing is not generally employed
outside the workplace now and would probably not be feasible during
a public health medical emergency.