Video Offers Guidance for Non-Prescription N95 Respirators

The FDA has released a guidance video for 3M's 8612F and 8670F respirators, the first FDA-cleared N95 respirators available without a prescription for use by the public during health emergencies. The video can be viewed in multiple formats at www.accessdata.fda.gov.

The devices, originally designed for occupational use and intended to filter out at least 95 percent of small airborne particulates, were approved for marketing by FDA on May 8, 2007.

An N95 respirator can be used in different circumstances than a surgical mask, isolation mask, or dental mask, and would be appropriate for those that are caring for an open wound, exposed to splattered blood, or vomit. The one-time-use respirators should be quickly discarded after use.

When used in occupational settings, each individual respirator is selected to fit the worker who will use it. 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. The 3M Company did evaluate the fit in a group of healthy volunteers, and although the results did vary from person to person, everyone achieved some reduction in exposure to airborne particulates.

FDA does caution that the respirators are sized for adults and may not form a proper fit on children. In addition, anything that comes between the respirator and the face, such as facial hair, may interfere with its fit. Also, people with pre-existing heart or lung disease may have difficulty breathing through a respirator.

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