Aug. 11, 2025
N95 respirators and surgical masks are examples of personal protective equipment that are used to protect the wearer from particles or from liquid contaminating the face. The Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) also regulates N95 respirators. The Department of Labor's Occupational Safety and Health Administration (OSHA) regulates entities for compliance with worker safety rules and OSHA standards, including, for example, the proper use of respirators in different work environments.
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It is important to recognize that the optimal way to prevent transmission of microorganisms, such as viruses, is to use a combination of interventions from across the hierarchy of controls, not just PPE alone.
A face mask is a product that covers the wearer's nose and mouth. Face masks are for use as source control by the general public and health care personnel (HCP) in accordance with CDC recommendations, and are not personal protective equipment. Face masks may or may not meet any fluid barrier or filtration efficiency levels; therefore, they are not a substitute for N95 respirators or other Filtering Facepiece Respirators (FFRs), which provide respiratory protection to the wearer, or for surgical masks, which provide fluid barrier protection to the wearer.
A barrier face covering, as described in ASTM F-21, is a product worn on the face specifically covering at least the wearer's nose and mouth, with the primary purpose of providing source control and to provide a degree of particulate filtration to reduce the amount of inhaled particulate material. Barrier face coverings are not a substitute for N95 respirators and other Filtering Facepiece Respirators (FFRs), which provide respiratory protection to the wearer, or for surgical masks, which provide fluid barrier and particulate material protection to the wearer.
Barrier face coverings may be made from a variety of materials that are not flammable. By definition, a barrier face covering should meet the particulate filtration efficiency, airflow resistance, and leakage assessment recommendations as described in ASTM F-21.
A surgical mask 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. Surgical masks are regulated under 21 CFR 878.. Surgical masks 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. These are sometimes referred to as face masks, as described above, although not all face masks are regulated as surgical masks.
Surgical masks 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 face mask and how well the surgical mask protects you.
If worn properly, a surgical mask 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. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others.
While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, it does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.
Surgical masks are not intended to be used more than once. If your surgical mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove it, discard it safely, and replace it with a new one. To safely discard your surgical 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. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.
The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.
A surgical mask 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. These are often referred to as face masks, although not all face masks are regulated as surgical masks. Note that the edges of the mask are not designed to form a seal around the nose and mouth.
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth.
Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.
Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles. They 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).
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 surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878., and CDC NIOSH under 42 CFR Part 84.
N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:
The FDA has a Memorandum of Understanding (MOU) with CDC NIOSH which outlines the framework for coordination and collaboration between the FDA and NIOSH for regulation of this subset of N95 respirators.
Get answers to your questions about face masks, including how to use them properly.
By Mayo Clinic StaffCan face masks help slow the spread of the virus that causes coronavirus disease (COVID-19)?
Yes. When used with measures such as getting vaccinated, hand-washing and physical distancing, wearing a face mask slows how quickly the virus that causes COVID-19 spreads.
The U.S. Centers for Disease Control and Prevention (CDC) recommends wearing masks if you choose to, and in specific places and situations.
In areas that have many people with COVID-19 in the hospital, the CDC recommends wearing a face mask indoors in public.
The CDC says that you should wear the most protective mask that you'll wear regularly, fits well and is comfortable.
Respirators such as nonsurgical N95s give the most protection. KN95s and medical masks provide the next highest level of protection. Cloth masks provide less protection. The CDC says that surgical N95 masks should be reserved for health care professionals.
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Masking suggestions are a bit different for people at higher risk of serious illness. This includes people with risk factors such as older age. It also includes people with weakened immune systems and those who live with or care for someone with these risk factors.
For people at high risk, the CDC suggests you wear a mask that provides you with the most protection possible. Wear a mask while in public indoor spaces when your area has a high number of people with COVID-19 in the hospital.
Check with your doctor to talk about when to wear a mask at other times.
Also called surgical masks, these are loosefitting disposable masks. They're meant to protect the wearer from contact with droplets and sprays that may contain germs. A medical mask also filters out large particles in the air when the wearer breathes in.
To make medical masks more form-fitting, knot the ear loops where they attach to the mask. Then fold and tuck the loose material under the edges.
Wearing a medical mask doesn't increase the level of carbon dioxide in the air you breathe.
A KN95 mask is a type of respirator that meets certain international standards. It offers more protection than a medical mask does because it filters out both large and small particles when the wearer inhales. But be cautious when buying a KN95. Some may not meet the quality standards, so consider researching the source carefully.
An N95 mask is a type of respirator that meets U.S. quality standards. An N95 offers the highest level of protection. It offers more protection than a medical mask does because it filters out both large and small particles when the wearer inhales. Nonsurgical N95s can be used by the general public.
The CDC has said surgical N95 masks should be reserved for health care professionals. Like surgical masks, N95 masks are intended to be disposable. But researchers are testing ways to disinfect and reuse them.
To work best, N95 masks should fit your face tightly.
Some N95 masks, and even some cloth masks, have valves that make them easier to breathe through. But these masks don't filter the air the wearer breathes out. For this reason, they've been banned in some places.
A cloth mask is intended to trap respiratory droplets released when the wearer talks, coughs or sneezes. It also acts as a barrier to protect the wearer from breathing in droplets released by others.
The most effective cloth masks are made of many layers of tightly woven fabric like cotton. A mask with layers will stop more droplets from getting through the mask or escaping from it.
Wearing a mask doesn't increase the level of carbon dioxide in the air you breathe.
Your mask works best if it fits your face closely and has no gaps around the edges. This helps air and breath move through the mask, not around the edges.
You should feel warm air going out the front of the mask when you breathe out. You shouldn't feel your breath coming out under the edges of the mask.
Use masks that have bendable nose strips, as these help prevent air from leaking out of the top of the mask.
Layers of material offer more protection.
Some people choose to wear a medical mask under a cloth mask. In that case, the cloth mask should press the edges of the medical mask against the face. Don't add layers if they make it hard to breathe or block your vision. And don't use another mask with a KN95 or N95 mask.
If you wear a KN95 or N95 mask, make sure it fits and seals close to your face.
A child's mask should be specifically made for children in order to fit properly. Make sure it fits close over the nose, mouth and chin.
Proper use, storage and cleaning of masks also affects how well they protect you. Follow these steps for putting on and taking off your mask:
And don't forget these precautions:
Experts do not recommend using face shields instead of masks. It's not clear how much protection shields provide. But wearing a face mask may not be possible in every situation. If you must use a face shield instead of a mask, choose one that wraps around the sides of your face and extends below your chin.
After getting vaccinated, you can more safely return to doing activities that you might not have been able to do because of high numbers of people with COVID-19 in your area. However, if you are in an area with a high number of people with COVID-19 in the hospital, the CDC recommends wearing a mask indoors in public. You are considered up to date with your vaccines if you have gotten all recommended COVID-19 vaccine shots when you become eligible.
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