Q: Is there a difference between a face mask, a barrier face covering, a surgical mask, and a respirator?

A: Face masks, barrier face coverings, surgical masks, and respirators all cover a wearer's nose and mouth, but they differ in several aspects.

• Face masks: A mask, with or without a face shield, that covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks should be used by the general public and health care personnel as source control in accordance with CDC recommendations on Interim Infection Prevention and Control, or in other situations as appropriate based on personal circumstances.
• Barrier face coverings: As described in ASTM F3502-21, a barrier face covering 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 matter.
• Surgical masks: A mask intended for medical purposes that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks are Class II medical devices. These masks meet certain fluid barrier protection standards and flammability requirements (that is, Class I or Class II, per 16 CFR 1610.4). Surgical masks are also tested for particulate and bacterial filtration efficiencies and biocompatibility and are considered personal protective equipment (PPE). While surgical masks may be effective in blocking splashes and large-particle droplets, they do not provide a reliable level of protection from aerosolized particles because of the loose fit between the surface of the mask and your face. Surgical masks are not respiratory protective devices, such as respirators.
• Respirators: Air purifying respirators, known as respirators, including filtering facepiece respirators (FFRs) such as N95s and surgical N95s, filter at least 95 percent of airborne particles. They are PPE that tightly fit the face and provide certain filtration efficiency levels to help reduce wearer exposure to pathogenic particles in a health care setting. They provide a higher level of protection against viruses and bacteria when properly fit-tested.

Q: Which face masks, barrier face coverings, and surgical masks are medical devices regulated by the FDA?

A: The FDA regulates face masks, including cloth face coverings, barrier face coverings, and surgical masks as medical devices when they are intended for a medical purpose. Medical purposes include uses related to helping prevent the spread of COVID-19. Face masks intended for use by the general public for non-medical purposes, such as for use in construction and other industrial applications, are not medical devices.

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 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. 

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.

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.

• 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.

Wear Your N95 Properly So It Is Effective

• N95s must form a seal to the face to work properly. This is especially important for people at increased risk for severe disease. Wearing an N95 can make it harder to breathe. If you have heart or lung problems, talk to your doctor before using an N95.
• Some N95s may contain latex in the straps. If you have natural rubber latex allergies, see the manufacturers’ website for information about your specific model.

Your N95 may look different than the one in these pictures. As long as your N95 has two head straps (not ear loops), these basic instructions apply.

When to Replace Your N95

Do not wash your N95 or put it in the oven or microwave to try to sterilize it. Replace the N95 when the straps are stretched out and it no longer fits snugly against your face or when it becomes wet, dirty, or damaged. Throw it in the trash.

Q: Do face masks and barrier face coverings provide protection from coronavirus?

A: Face masks and barrier face coverings should generally be used for source control, meaning they may help prevent people who have COVID-19 from spreading the virus to others. These products may also help limit exposure to respiratory droplets and large particles but are not a substitute for filtering facepiece respirators or surgical masks.

Q: Are face masks, barrier face coverings, surgical masks, and respirators safe to wear?

A: If worn properly, face masks, barrier face coverings, surgical masks, or respirators may reduce the chance of spreading a COVID-19 infection between you and those around you.

FDA-cleared surgical masks and respirators have been used by health care personnel for years and have been worn in health care facilities during extended procedures without harm to the wearer. Health care personnel with medical conditions should discuss concerns they may have with wearing respirators with their own health care providers. Health care personnel should follow the manufacturer's instructions and their facility's policies for use of all PPE.

Q: What does wearing a face mask or a barrier face covering for 'source control' mean?

A: Source control refers to a person's use of barrier face coverings or face masks, including cloth face coverings, to cover the person's mouth and nose when they are talking, sneezing, or coughing to reduce the likelihood of transmission of infection by preventing the spread of respiratory secretions and large particles. COVID-19 may be spread by individuals who may or may not have symptoms of COVID-19.

The general public's use of cloth face coverings made from common, easily accessible materials, are an additional public health approach to help slow the spread of COVID-19.

Barrier face coverings and face masks, including cloth face coverings, intended for a medical purpose, such as prevention of infectious disease transmission, are subject to FDA regulation. The FDA has issued a policy of regulatory flexibility for such products, as well as an emergency use authorization (EUA) for face masks.

Q:How can health care facilities know if there may be a shortage so they can prepare?

A: The FDA provides information on medical device shortages during the COVID-19 public health emergency.

The FDA is interested in hearing from health care facilities and other stakeholders about shortages and potential shortages they may be experiencing. You may email the FDA at deviceshortages@fda.hhs.gov.

Q: How do I know what the manufacturer-designated shelf life is?

A: The manufacturer-designated shelf life or expiration date may be found on the product labeling or packaging, or you can contact the manufacturer directly.

Q: Can face masks and barrier face coverings be cleaned and reused during COVID-19?

A: The CDC recommends reusable face masks be washed after each use and provides information on the washing of cloth face masks.

The reuse of barrier face coverings should be determined based upon the manufacturer's instructions, which may include washing and subsequent wear.

The user should inspect all masks prior to use and, if there are concerns such as degraded materials (such as elastic) or visible tears, the product should be discarded.

Q: My supply of respirators is running low. What are the best strategies to conserve respirators during COVID-19? Can filtering facepiece respirators (FFRs) such as N95s be reused during COVID-19?

A: The CDC provides additional information on Strategies for Optimizing the Supply of N95 Respirators. Reuse of FFRs is currently not recommended.

Q: Can I still use non-NIOSH-approved FFRs that are no longer authorized by FDA?

A: The FDA realizes that stakeholders such as health care facilities and states may continue to have a supply of non-NIOSH-approved FFRs that were authorized prior to FDA's July 6, 2021 revocation of both EUAs concerning non-NIOSH-approved FFRs. The Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) explains that the FDA generally does not intend to object, for the duration of the public health emergency, to the further distribution and use of existing stockpiles of non-NIOSH-approved disposable FFRs for use as face masks for source control by the general public and HCP without compliance with certain regulatory requirements, where such use does not create an undue risk in light of the public health emergency. More information is included in the guidance.

Q: Why does the FDA issue Emergency Use Authorizations (EUAs)?

A: EUAs authorize the emergency use of unapproved medical devices. The EUA authority allows the FDA to help strengthen the nation's public health protections against emerging infectious disease threats by facilitating the availability and use of medical devices needed during public health emergencies.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may authorize the emergency use of an unapproved or uncleared medical product or an unapproved / uncleared use of an approved/cleared medical product for certain emergency circumstances after the HHS Secretary has made a declaration of emergency or threat justifying emergency use. The FDA Commissioner may issue an EUA to authorize a medical product for use in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, or available alternatives when certain criteria for issuance are met. The Emergency Use Authorizations (EUAs) for diagnostic, non-diagnostic, and therapeutic medical devices that the FDA has issued related to COVID-19 may be revised, terminated, or revoked as appropriate.

For details on the Emergency Use Authorizations for these devices, see:

• Personal Protective Equipment EUAs
• Face Mask EUA (PDF - 98KB)

Q: What is a pre-EUA?

A: To help prepare for potential and current emergencies, the FDA works with medical device developers to prepare pre-EUA packages when appropriate. A pre-EUA package contains data and information about the safety, quality, and effectiveness of the product, its intended use, and information about the emergency or potential emergency. The pre-EUA process allows the FDA's scientific and technical subject matter experts to begin a review of information and consideration of the EUA statutory criteria, assist in the development of conditions of authorization, fact sheets, and other documentation that would be needed for an EUA, and also helps to facilitate completion of EUA requests during a current emergency declaration.

Q: What is an Umbrella EUA?

A: Many EUAs apply only to a specific medical device. Generally, an umbrella EUA authorizes many devices that meet specific criteria for that device type, helping to facilitate access to those devices by streamlining the process associated with EUAs (for example, EUA request submission and FDA authorization) for any medical devices that meet the requirements within the EUA.

Q: What type of mask is authorized under the umbrella EUA for surgical masks?

A: The FDA issued an umbrella EUA in response to insufficient availability of disposable, single-use surgical masks. Surgical masks within the Scope of Authorization of this EUA are authorized for emergency use in health care settings by health care personnel as PPE.

The Scope of Authorization includes performance metrics that must be met including liquid barrier performance, particulate filtration efficiency, air flow resistance, and use of biocompatible, non-cytotoxic, non-irritating, and non-sensitizing materials. Surgical masks that have been confirmed by the FDA to be within the Scope of Authorization are listed in Appendix A of the EUA as authorized surgical masks.

To be added to Appendix A, test reports must be submitted to the FDA demonstrating that the surgical mask meets the performance criteria. Requests can be submitted to the FDA with the subject line "Surgical Masks EUA" to CDRH-nondiagnosticEUA-templates@fda.hhs.gov. The Surgical Masks EUA Template for Addition to Appendix A (DOCX - 56KB) can be used to provide the required information.

Manufacturers, importers, and distributors must also comply with the conditions of authorization found in Section IV of the EUA Letter of Authorization (PDF - 101KB).

The following surgical masks are not within the scope of this EUA:

• Surgical masks that are FDA-cleared
• Surgical masks that are manufactured in China
• Surgical masks that include drugs, biologics, nanoparticles, or antimicrobial/antiviral agents

Q. Since the FDA has removed this product code from the device shortages list, will the Umbrella EUA for Surgical Masks and enforcement policies be revoked?

A: The removal of a product code from the device shortages list does not impact the existing Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency or Umbrella EUA for surgical masks at this time. The policy and EUAs remain in effect at this time.

Q. What types of respirators are authorized under the umbrella EUA for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency?

A: Respirators authorized by this EUA (PDF - 176KB) include:

1. Non-powered air-purifying particulate FFRs and reusable respirators such as elastomeric half and full facepiece respirators, approved by NIOSH in accordance with 42 CFR Part 84 and listed on the NIOSH Certified Equipment list (CEL) for non-powered air purifying respirators with particulate protection; and
2. Other powered air purifying respirators (PAPRs) approved by NIOSH, in accordance with 42 CFR Part 84, and that are listed on the NIOSH CEL for PAPRs with particulate protection

Q. If I am producing surgical masks or respirators under an EUA during COVID-19, what do I need to do to continue marketing my product after the emergency is over?

A: Manufacturers must submit marketing applications under the traditional premarket pathways in order to continue marketing their products if the applicable emergency use authorization is revoked.

Device manufacturers are encouraged to pursue marketing applications through the appropriate regulatory pathway (such as 510(k), De Novo request, or PMA) during the emergency so that devices can remain on the market once the EUA is no longer in effect. For more information, see FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic.