- About Facemasks and N95 Respirators
- N95 Respirators
- N95 Respirators for Use by the Public
- N95 Respirators in Industrial and Health Care Settings
- General N95 Respirator Precautions
- Additional Information
Facemasks and N95 respirators are examples of personal protective equipment that are used to protect the wearer from liquid and airborne particles contaminating the face. They are one part of an infection-control strategy.
A facemask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Facemasks are not to be shared and may be labeled as surgical, isolation, dental or medical procedure masks. They may come with or without a face shield.
Facemasks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the facemask and how well the facemask protects you.
If worn properly, a facemask is meant to help block large-particle droplets, splashes, sprays or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Facemasks may also help reduce exposure of your saliva and respiratory secretions to others.
While a facemask may be effective in blocking splashes and large-particle droplets, a facemask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes or certain medical procedures. Facemasks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the facemask and your face.
Facemasks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the facemask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask.
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.
The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death.
N95 respirators are not designed for children or people with facial hair. Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection.
FDA has cleared certain filtering facepiece respirators (N95) for use by the general public. To work as expected, an N95 respirator requires a proper fit to your face. Generally, to check for proper fit, you should put on your respirator and adjust the straps so that the respirator fits tightly but comfortably to your face. For information on proper fit, refer to the manufacturer’s instructions. The Centers for Disease Control and Prevention (CDC) does not generally recommend facemasks and respirators for use in home or community settings. However, they may be appropriate for persons at increased risk of severe illness from influenza or other respiratory diseases. Please consult with your health care provider for more information about when to use N95 Respirators at home or in the community.
FDA has cleared the following N95 respirators for use by the general public in public health medical emergencies:
- 3M™ Particulate Respirator 8670F
- 3M™ Particulate Respirator 8612F
- Pasture Tm F550G Respirator
- Pasture Tm A520G Respirator
These devices are labeled "NOT for occupational use.”
Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles are regulated by the National Personal Protective Technology Laboratory (NPPTL) in the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control and Prevention (CDC). These products are labeled "For occupational use."
However, some N95 respirators are intended for use in a healthcare setting. Specifically, single-use, disposable respiratory protective devices used and worn by healthcare personnel during procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These N95 respirators are class II devices regulated by FDA, under 21 CFR 878.4040, and CDC NIOSH. Subject to certain conditions and limitations, N95s regulated under product code MSH are exempt from 510(k) premarket notification. FDA has a Memorandum of Understanding (MOU) with the CDC NIOSH which outlines the framework for coordination and collaboration between FDA and NIOSH for regulation of this subset of N95 respirators.
People with chronic respiratory, cardiac, or other medical conditions that make breathing difficult should check with their healthcare provider before using an N95 respirator because the N95 respirator can make it more difficult for the wearer to breathe. Some models have exhalation valves that can make breathing out easier and help reduce heat build-up. Note that N95 respirators with exhalation valves should not be used when sterile conditions must be maintained.
All FDA-cleared N95 respirators are labeled as "single use", disposable devices. If your respirator is damaged or soiled, or if breathing becomes difficult, you should remove the respirator, discard it properly, and replace it with a new one. To safely discard your N95 respirator, place it in a plastic bag and put it in the trash. Wash your hands after handling the used respirator.
For more information on the proper use and removal of masks and respirators, visit:
- CDC - NIOSH - NPPTL Respirator Trusted-Source, Ancillary Respirator Information, Healthcare FAQ
- FDA – CDC/NIOSH Memorandum of Understanding for N95 Regulatory Oversight