This page provides information on FDA-regulated face masks (including cloth face coverings), surgical masks, and respirators (filtering facepiece respirators, such as N95 respirators) intended for a medical purpose to assist in preventing the spread of infectious materials during the COVID-19 pandemic.
This page does not cover:
- Powered respirators, such as powered air purifying respirators (PAPRs)
- Face shields
- Non-health care use of face masks and respirators intended to limit industrial or general exposure to non-infectious particles, such as during construction or other industrial use.
The information provided may be useful to manufacturers and importers of face masks, surgical masks, and respirators, as well as health care facilities and health care personnel.
To help expand the availability of face masks (including cloth face coverings), surgical masks, and respirators, the FDA is providing certain regulatory flexibility for the duration of the COVID-19 public health emergency, as described in the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), and has issued emergency use authorizations (EUAs) for face masks, surgical masks, and respirators that meet certain criteria. The FDA regularly updates its communications about face masks, surgical masks, and respirators, including the answers to frequently asked questions on this page.
On this page:
- The basics on face masks, surgical masks, and respirators
- Using face masks, surgical masks, and respirators
- Shortages of face masks, surgical masks, and respirators during the COVID-19 pandemic
- Emergency Use Authorizations for face masks, surgical masks, and respirators
- Manufacturing and importing face masks, surgical masks, and respirators during the COVID-19 pandemic
- Purchasing or donating face masks, surgical masks, and respirators during the COVID-19 pandemic
- Reporting shortages of or problems with face masks, surgical masks, or respirators
A: Face masks, 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 that are not intended for a medical purpose are not considered medical devices. Face masks may be used by the general public and health care personnel as source control in accordance with CDC recommendations on Interim Infection Prevention and Control.
- Surgical masks: A mask that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks intended for medical purposes are considered medical devices. The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests. Surgical masks are also tested for biocompatibility and are considered personal protective equipment (PPE). While a surgical mask may be effective in blocking splashes and large-particle droplets, they 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 respiratory protective devices such as respirators.
- Respirators, known as filtering facepiece respirators (FFRs), including 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 airborne particles in a health care setting. They provide a higher level of protection against viruses and bacteria when properly fit-tested.
This CDC infographic (PDF - 227KB) explains the differences between surgical masks and N95 respirators.
A: The FDA regulates face masks, including cloth face coverings, and surgical masks as medical devices when they are marketed for medical purposes. Medical purposes include uses related to COVID-19, such as face masks to help stop the spread of disease, surgical masks, and surgical masks with antimicrobial/antiviral agents. Face masks marketed to the general public for general non-medical purposes, such as for use in construction and other industrial applications, are not medical devices.
A: Masks may help prevent people who have COVID-19 from spreading the virus to others. The CDC recommends people wear face masks in public settings, especially when other social distancing measures are difficult to maintain. Wearing a face mask may limit exposure to respiratory droplets and large particles and may help prevent people who have COVID-19 from spreading the virus.
A: If worn properly, face masks, surgical masks, or respirators may reduce the chance of spreading a COVID-19 infection between you and those around you. The CDC provides information on Using PPE and Considerations for Wearing Masks.
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.
A: Source control refers to use of cloth face coverings or face masks to cover a 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. 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 voluntary public health approach to help slow the spread of COVID-19. The CDC has information on the Use of Masks to Help Slow the Spread of COVID-19 for the general public.
Face masks intended for a medical purpose, such as prevention of infectious disease transmission, are subject to FDA regulation. The FDA has issued an emergency use authorization (EUA) as well as guidance on regulatory flexibility for such products. For more information, see "I'm interested in manufacturing face masks or surgical masks for the COVID-19 pandemic. What do I need to do?"
For more information on source control, see the CDC's Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic.
A: During the COVID-19 public health emergency, the CDC recommends health care personnel wear face masks at all times while they are in the health care facility, including in breakrooms or common areas where they might encounter co-workers or visitors.
When available, surgical masks (a specific type of face mask) are preferred over cloth face coverings for health care personnel as surgical masks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others.
- Cloth face coverings should NOT be worn instead of a respirator or surgical mask if more than source control is needed.
- Wear an N95 or equivalent or higher-level respirator, instead of a face mask, for:
- Aerosol generating procedures (refer to "Which procedures are considered aerosol generating procedures in healthcare settings?" on the CDC's Clinical Questions about COVID-19: Questions and Answers page).
- Surgical procedures that might pose a higher risk for transmission if the patient has COVID-19 (for example, that generate potentially infectious aerosols or involve anatomic regions where viral loads might be higher, such as the nose and throat, oropharynx, or respiratory tract). Refer to "During the COVID-19 pandemic, are there special considerations for surgical and other procedural care settings, including performance of aerosol-generating procedures (AGPs)?" on the CDC's Clinical Questions about COVID-19: Questions and Answers page.
- Health care personnel should consult their institutional policies for further guidance on what type of face mask or respirator to use.
The CDC provides information on infection control measures for COVID-19 on its Clinical Questions about COVID-19: Questions and Answers page
A: The FDA provides information on medical device shortages during the COVID-19 public health emergency and maintains a list of devices that it has determined to be either in shortage or permanently discontinued. Health care facilities may review the list of device types to determine which devices may be included in the shortage or discontinuation lists.
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 email@example.com.
A: The FDA issued a Letter to Health Care Providers on Surgical Mask and Gown Conservation Strategies that describes these recommended strategies:
- Conventional capacity strategies
- Contingency capacity strategies
- Crisis or alternate strategies if surgical masks are running low or not available
A: Face masks and surgical masks are designed to serve as protective barriers and may still offer some protection even if they are used beyond the manufacturer's designated shelf life or expiration date. If there is no date available on the face mask label or packaging, facilities should contact the manufacturer. 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. For additional information please refer to the CDC's Strategies for Optimizing the Supply of Facemasks.
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.
A: The CDC does not recommend the reuse of disposable surgical masks that are intended to be used once. The FDA recognizes that there may be availability concerns with surgical masks during the COVID-19 public health emergency, but there are strategies to conserve surgical masks.
A: The CDC recommends reusable face masks be washed after each use and provides information on the cleaning of cloth face masks.
A: The CDC considers N95-type FFRs a one-time-use product and recommends that cleaning, decontamination, and subsequent reuse of FFRs should only be used when there is a critical shortage of FFRs and should only be performed on NIOSH-approved FFRs without exhalation valves. For additional details, see the CDC's Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings and the CDC's recommendations on Implementing Filtering Facepiece Respirator (FFR) Reuse, Including Reuse after Decontamination, When There Are Known Shortages of N95 Respirators.
The FDA has issued Emergency Use Authorizations (EUAs) for devices that decontaminate certain respirators. Health care facilities should check the Decontamination Systems for Personal Protective Equipment EUAs for the most up-to-date information.
FFR decontamination may be an effective method of reducing the pathogen burden. The process used by EUA-authorized decontamination devices should not harm the fit or filtration performance of the FFR and should present no residual chemical hazard to the FFR user. For additional details, see the FDA's Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Surgical Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
A: EUAs authorize the use of medical devices that are not FDA-cleared or approved. 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. 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 needed.
For details on the Emergency Use Authorizations for these devices, see:
If you need help with the EUA process for face masks, surgical masks, or respirators, contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.
There are currently no FDA-approved face masks, surgical masks, or respirators. To identify FDA-cleared face masks, surgical masks, and respirators, search the 510(k) Premarket Notification database.
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 situation. 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.
If you need help with the pre-EUA process for face masks, surgical masks, or respirators, contact CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.
For additional information, refer to Emergency Use Authorization of Medical Products and Related Authorities.
A: Many EUAs apply only to a specific medical device. Generally, an umbrella EUA authorizes many categories of devices that meet specific criteria, 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.
A: The FDA issued an umbrella EUA in response to insufficient availability of disposable, single-use surgical masks. This EUA established performance criteria for the surgical mask to be authorized for use in health care settings by health care personnel as PPE.
Performance criteria that must be met include 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 meet the criteria 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-nondiagnosticEUAfirstname.lastname@example.org. 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 covered in 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
A: Respirators authorized by this EUA (PDF - 176KB) include:
- Non-powered air-purifying particulate FFRs and reusable respirators such as elastomeric half and full facepiece respirators, approved by NIOSH.
- Other powered air purifying respirators (PAPRs) approved by NIOSH.
- FFRs that were NIOSH-approved but have since passed the manufacturers' recommended shelf life, are not damaged, and have been held in accordance with manufacturers' storage conditions in strategic stockpiles (referred to as expired FFRs).
- Any authorized respirator under (1) or (3) above that has been decontaminated pursuant to the terms and conditions of an authorized decontamination system.
For more information, see CDC/NIOSH recommendations in Considerations for Release of Stockpiled N95 Beyond the Manufacturer-Designated Shelf Life.
A: A disposable non-NIOSH-approved respirator manufactured in China is authorized under this EUA if it is listed in Appendix A as of October 15, 2020, which is when the umbrella EUA (PDF - 87KB) was reissued. This EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria.
A: This EUA (PDF - 159KB) authorizes the emergency use of the following Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs):
- Disposable FFRs that have been designed, evaluated, and validated to meet a given performance standard and have corresponding acceptable product classifications as identified in Table 1 of the EUA.
- Disposable FFRs that conform to Personal Protective Equipment (PPE) Directives as evidenced by a European Conformity (CE) mark, and the CE mark has been authenticated and verified by the FDA.
- Disposable FFRs that are manufactured by entities that hold NIOSH approval, that have been verified by the FDA, and that are produced by the NIOSH approval holder under the authorization standards of another country.
- Non-valved, authorized FFRs (authorized respirators without exhalation valves) that are decontaminated using an authorized or cleared decontamination system.
Exhibit 1: Authorized Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators will be updated as additional respirators are authorized.
A: For medical products and uses that are not approved, cleared, or licensed to continue legally marketing their devices after the public health emergency is over, manufacturers may submit marketing applications under the traditional premarket pathways.
Device manufacturers are encouraged to pursue marketing applications through the appropriate regulatory pathway (such as 510(k), De Novo request, 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.
Manufacturing and Importing Face Masks, Surgical Masks, and Respirators During the COVID-19 Pandemic
A: Face masks intended for a medical purpose, such as prevention of infectious disease transmission, are subject to FDA regulation. The FDA has issued guidance on regulatory flexibility for such products, as well as several EUAs.
The guidance provides an enforcement discretion policy for face masks intended for a medical purpose for COVID-19, such as for use as source control. The FDA does not intend to enforce certain regulatory requirements, including 510(k) premarket notification, Quality System Regulations (QSR), establishment registration and device listing, reporting under 21 CFR Part 806, and unique device identification (UDI).
These face masks, intended for use by health care personnel and the general public as source control to help stop the spread, may be authorized under the umbrella EUA for face masks (PDF - 92KB) without submitting documentation to the FDA if the face mask meets the EUA eligibility requirements. A face mask authorized under this EUA must comply with the Conditions of Authorization (Section IV) of the EUA.
For a surgical mask to be added to the Surgical Mask EUA Appendix A, test reports must be submitted to the FDA demonstrating that the surgical mask meets the performance criteria for liquid barrier protection. Requests can be submitted to the FDA with the subject line "Surgical Masks EUA" to CDRH-nondiagnosticEUAemail@example.com. The Surgical Masks EUA Template for Addition to Appendix A (PDF - 176KB) can be used to provide the required information.
Manufacturers, importers, and distributors of surgical masks 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 covered in 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.
A: The answer depends in part on where you are manufacturing respirators.
- If you are manufacturing in the United States, the respirator requires NIOSH approval. Once NIOSH approval is obtained, the respirator is authorized under the EUA for NIOSH-approved air-purifying respirators (PDF - 176KB). In some cases (for example, if claimed to prevent specific diseases or infection, or if it includes antimicrobials or other additives), obtaining FDA clearance may be the appropriate pathway (see 21 CFR 878.4040).
- If you are manufacturing in China, you need to have a NIOSH approval or your respirator(s) must be authorized under the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (PDF - 87KB) and be listed in Appendix A as of the October 15, 2020 reissuance of this EUA. The FDA will no longer be reviewing requests and adding new respirator models to Appendix A as of the EUA's October 15 reissuance.
- If you are a foreign manufacturer not in China and do not have a NIOSH approval for the model(s) you wish to import, your respirator(s) must be authorized under the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) (PDF - 159KB).
Additional information can be obtained by reviewing the Manufacturing and Distributing Respirators for Health Care Use in the United States Under an Existing Emergency Use Authorization EUA) During the COVID-19 Pandemic flowchart.
A: The Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency provides guidance on manufacturing or importing face masks, surgical masks, and respirators. Device Advice provides comprehensive regulatory assistance to manufacturers and importers. If you have additional questions, you may send an email to CDRH-COVID19-PPE@fda.hhs.gov.
A: To help avoid delays of legitimate shipments, review Importing COVID-19 Supplies and Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 for important information from the FDA on importing products, including face masks, surgical masks, and respirators to ensure that the proper documentation is submitted at the time of entry.
The FDA is ready and available to engage with importers to help minimize disruptions during the importing process. If you have any specific import questions related to COVID-19, you may email COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.
A: The FDA does not maintain a list of face mask, surgical mask, or respirator suppliers. If you are a health care facility, check with your supplier, distributor, or your local health department.
You may also want to check with the Association for Health Care Resource & Materials Management (AHRMM) of the American Hospital Association, which maintains the AHRMM Novel Coronavirus (COVID-19) Update on health care supply chain issues and includes vetted non-traditional supplies, companies offering supplies at no cost, and alternate supply channels.
A: The FDA does not have a list of all counterfeit or fraudulent products. To report fraudulent COVID-19 products to the FDA, email FDA-COVID-19-Fraudulent-Products@fda.hhs.gov. The CDC provides information on identifying counterfeit respirators at Counterfeit Respirators / Misrepresentation of NIOSH-Approval.
A: The FDA does not purchase or distribute face masks, surgical masks, or respirators. You can contact your local health department to determine if there are donation programs available in your area.
The FDA encourages health care facilities which anticipate a potential shortage or are experiencing an actual shortage to notify the FDA. For potential or actual supply issues, e-mail information to the FDA at firstname.lastname@example.org.
Certain device manufacturers are now required under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to notify the FDA of an interruption or permanent discontinuance in manufacturing. Section 506J of the FD&C Act requires manufacturers to notify the FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States.
The FDA has issued a guidance to assist manufacturers in providing the FDA with timely and informative notifications about these changes in the production of certain medical device products. These notifications will help the FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency.
The FDA has prepared a list of medical device types and corresponding product codes identifying devices that the FDA believes are critical to the public health during the COVID-19 pandemic. This list is not exhaustive, and the FDA intends to update this list as the COVID-19 pandemic evolves.
Manufacturers of device types that are included on this list should review section 506J of the FD&C Act and FDA's guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency, to determine whether they are required to notify the FDA.
Manufacturers should submit their notifications by email to CDRHManufacturerShortage@fda.hhs.gov during the COVID-19 Public Health Emergency. Please begin the email subject line with the word "Notification."
A: The FDA encourages reporting of any adverse events or suspected adverse events experienced with face masks, surgical masks, or respirators.
- In general, device manufacturers, importers, and device user facilities (health care facilities) must comply with the applicable medical device Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.
- Voluntary reports from health care personnel and users can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Health care personnel employed by organizations that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their organizations.