N95 Respirators, Surgical Masks, Face Masks, & Barrier Face Coverings (2024)

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.

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.

COVID-19 Resources on Respirators and Masks

Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19: Answers to frequently asked questions

On this page:

  • Face Masks
  • Barrier Face Coverings
  • Surgical Masks
  • N95 Respirators
  • Comparing Surgical Masks and Surgical N95 Respirators
  • General N95 Respirator Precautions
  • N95 Respirators in Industrial and Health Care Settings

Face Masks

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.

Barrier Face Coverings

A barrier face covering, as described in ASTM F3502-21, 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 F3502-21.

Surgical Masks

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 878.4040. 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.

N95 Respirators

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.

Comparing Surgical Masks and Surgical N95 Respirators

The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.

N95 Respirators, Surgical Masks, Face Masks, & Barrier Face Coverings (1)

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.

N95 Respirators, Surgical Masks, Face Masks, & Barrier Face Coverings (2)

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.

General N95 Respirator Precautions

  • People with chronic respiratory, cardiac, or other medical conditions that make breathing difficult should check with their health care 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 are needed.
  • 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.
  • 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.

N95 Respirators in Industrial and Health Care Settings

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 878.4040, 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 respirator is intended to prevent specific diseases or infections, or
  • The respirator is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or
  • The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).

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.

For additional differences between surgical masks and N95 respirators, please see CDC's infographic.

N95 Respirators, Surgical Masks, Face Masks, & Barrier Face Coverings (2024)

FAQs

Are N95 respirators the same as N95 masks? ›

Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.

Which is better, KN95 or N95? ›

Only N95 masks are approved for healthcare use in the U.S. KN95 masks have many of the same protective properties. CDC recommends that people be cautious about purchasing KN95 in the U.S. because many are fake and do not meet NIOSH requirements. N95 respirators are single-use, disposable devices.

How many times can I wear an N95? ›

N95 filtering facepiece respirators can be reused until they are dirty, damaged, or difficult to breathe through. You should inspect your N95 respirator before each time you put it on. If the straps or noseclip are broken, it's torn, dirty, or otherwise damaged, then you should dispose of it.

What is the problem with the N95 mask? ›

Wearing an N95 respirator can make it harder to breathe. If you have heart or lung problems, talk to your doctor before using an N95 respirator. Some N95 respirators may contain latex in the straps.

Can you reuse N95 masks? ›

The recommendations in this fact sheet provide advice for when to discard or reuse a KN95/N95 mask. Paying attention to the condition of your mask—and discarding damaged or contaminated masks—can greatly reduce the risk of contact transmission. Do not reuse a mask more than five times.

Can you sleep with a N95 mask on? ›

Wearing masks during sleep at night does not adversely affect cardiopulmonary function but it's uncomfortable, especially N95 mask.

How long do N95 masks last? ›

Pierre, MD, MPH, an infectious disease physician and medical director of public health programs at Boston Medical Center, told Health that it's possible to use the same respirator for up to a week. For people in high-risk settings, like healthcare facilities, it's best to toss the mask after a day.

Do N95 masks protect against mold? ›

An N95 mask protects you from breathing in small particles in the air such as dust and mold. It is designed to filter out at least 95% of the dust and mold in the air.

Are N95 masks washable? ›

Unlike cloth masks that can be washed and reused, N95s do not have as long of a lifecycle. For starters, they are not washable. One of the layers in the mask is electrostatic; it's meant to attract and trap particles in the air that's breathed in, Fabian explains.

Can N95 masks be washed? ›

To maintain the effectiveness of the mask, NEVER use these methods: Spraying or wetting with aerosol or liquid alcohol. Washing in soapy water. These methods can break down the inherent electrostatic charge that is key to the way an N95 filters small particles.

Do 3M N95 masks protect against COVID? ›

N95 masks, medical masks and home‐made masks can block 99.98%, 97.14% and 95.15% of virus in aerosols. The efficiencies of cloth masks with multiple layers are similar to those of surgical masks.

How long does it take to fit a N95 mask? ›

A “fit test” tests the seal between the respirator's facepiece and your face. It takes about 15-20 minutes to complete and should be performed at least annually. After passing a fit test with a respirator, you must use the exact same make, model, style, and size respirator on the job to ensure a proper fit.

Does wearing an N95 mask increase blood pressure? ›

asked healthy individuals to continuously wear an N95 mask and observed the effects, which included a significantly increased heart rate after 1 hour of mask-wearing, significantly increased blood pressure (BP) after light exercise, and significantly increased plasma levels of norepinephrine and methoxyadrenaline after ...

What are the long term effects of wearing N95 masks? ›

Study: Wearing N95 Mask Over Long Period Can Cause Cardiopulmonary Stress. Extended use of an N95 mask in daily life can cause various cardiopulmonary stresses, such as reduced respiration, elevated heart rate and blood pressure, and increased energy expenditure.

What does 95 mean in N95? ›

95: Masks ending in a 95, have a 95 percent efficiency. Masks ending in a 99 have a 99 percent efficiency. Masks ending in 100 are 99.97 percent efficient and that is the same as a HEPA quality filter. . 3 microns: The masks filter out contaminants like dusts, mists and fumes.

What is the difference between a mask and a respirator? ›

Wearing a NIOSH Approved® respirator reduces your exposure to hazards in the air. Masks are a less protective option. Examples include barrier face coverings (BFCs), disposable face masks, and cloth masks.

Is a procedure mask the same as an N95 respirator? ›

A KN95 mask is made to filter at least 95% of particles of size down to 3 microns in diameter. It permits 8% or less leakage, by Chinese standards. A medical procedure mask, or surgical mask, fits loosely and will stop large droplets and particles, but does not stop small droplets.

What are the limitations of N95 respirators? ›

1) N95 respirators ONLY filter out particulate contaminants. 2) N95 respirators do not protect you from: ➢ Chemical vapors/ gases ➢ Oxygen deficient atmosphere ➢ High risk exposures such as those created by aerosol-generating procedures (i.e., bronchoscopy, autopsy) and asbestos handling.

What is equivalent to N95 mask? ›

Based on this comparison, it is reasonable to consider China KN95, AS/NZ P2, Korea 1st Class, and Japan DS2 FFRs as “similar” to US NIOSH N95 and European FFP2 respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g. ...

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