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Masks and N95 Respirators

On this page:

• About surgical masks and surgical N95 respirators
• When to use surgical masks and surgical N95 respirators
• Types of masks and respirators used in patient care
• Choosing between surgical masks and surgical N95 respirators
• Non-medical respirators
• What you should know before using surgical masks and surgical N95 respirators
• Find all FDA-cleared surgical masks and surgical N95 respirators

About surgical masks and surgical N95 respirators

Surgical masks and surgical N95 respirators are disposable devices that cover the mouth and nose during medical procedures. They help protect the caregiver and patient against microorganisms, body fluids, and small particles in the air.

Surgical masks and surgical N95 respirators are regulated by the Food and Drug Administration (FDA). FDA evaluates the performance of these devices in areas including fluid resistance and filtration efficiency to ensure that they are at least as safe and effective as similar devices already on the market. FDA encourages manufacturers to follow specific performance standards for their masks, and FDA also requires that these products be produced using good manufacturing practices.

Respirators may also be certified by NIOSH (the National Institute for Occupational Safety and Health) in accordance with regulations in 42 CFR part 84. When a mask is both cleared by FDA as a surgical mask and certified by NIOSH as an N95 respirator mask, FDA calls it a "surgical N95 respirator."

For more information, see FDA’s Role in Regulating PPE.

When to use surgical masks and surgical N95 respirators

Use surgical masks and surgical N95 respirators to cover your mouth and nose when you may be splattered by or exposed to someone else’s body fluids (such as blood, respiratory secretions, vomit, urine or feces).

Types of masks and respirators used in patient care

Surgical masks

• include masks labeled as surgical, laser, isolation, dental, or medical procedure masks
• help protect against microorganisms, body fluids, and large particles in the air
• are designed to cover the mouth and nose loosely; not sized for individual fit
• help prevent exposure to the wearer’s saliva and respiratory secretions
• are made of soft materials and are comfortable to wear
• are usually packaged in boxes of single-use masks

Surgical N95 respirators

• are surgical masks that are designed to protect against small droplets of respiratory fluids and other airborne particles in addition to all the protection of surgical masks
• fit closely to form a tight seal over the mouth and nose
• require fit-testing and must be adjusted to your face to provide intended effectiveness
• may be uncomfortable due to tight fit
• are usually packaged as single devices or in boxes of single-use devices

Choosing between surgical masks and surgical N95 respirators

CDC recommends the use of surgical masks or surgical N95 respirators based on the ways that specific diseases are transmitted. For more information about CDC recommendations, see Infection Control in Healthcare Settings.

Choose a surgical mask to

• help protect yourself if you may be splattered by someone else's body fluids (such as blood, respiratory secretions, vomit, urine or feces).
• help protect others if you are performing surgery, are caring for an open wound, or if you are sick.

Choose a surgical N95 respirator to provide the same protections as a surgical mask AND

• help protect yourself if you will be exposed to very small particles (e.g., fine aerosolized droplets) such as those produced by coughing.
• care for persons with known or suspected pulmonary and laryngeal tuberculosis per Occupational Safety and Health Administration (OSHA) regulations.

Non-medical respirators

FDA regulates as devices those respirators and other articles that are intended for use in preventing or treating infectious disease. There are a variety of respirators available for various occupational exposures that do not make medical claims and are not regulated by FDA. Many of these respirators are intended to filter out particles of dust and mist from wood, metal, and masonry work. Non-medical respirators are available from many sources including hardware stores and online. Non-medical respirators may look very similar to one another and to respirators that are regulated by FDA. However, there are differences among these respirators and between these non-medical respirators and respirators that have been cleared by FDA as surgical N95 respirators.

Only respirators that have passed specific testing by NIOSH may be labeled as NIOSH-certified. Each NIOSH-certified respirator contains a rating, such as N95, which refers to its certified level of filtration efficiency. If a non-medical respirator is not labeled as NIOSH-certified, it has not been evaluated by the government to determine whether or not it works.

Although NIOSH-certified nonmedical respirators have met filtration efficiency requirements, they are not subject to the additional requirements of FDA-cleared surgical N95 respirators (i.e. fluid and flammability resistance).

• Additional Information About Respirators for Public Health Emergencies

What you should know before using surgical masks and surgical N95 respirators

• The use of surgical masks and surgical N95 respirators alone will not fully protect you from acquiring an infection. Other infection control practices such as hand-washing, isolating infected patients, and practicing appropriate coughing etiquette, are also important to minimize your risk of infection.
• Surgical N95 respirators must be fit properly. A surgical N95 respirator that has not been fitted properly may leave unprotected gaps between the respirator and your face. These gaps will impair the respirator’s effectiveness. Facial hair or unusual facial features make it difficult to fit surgical N95 respirators properly.
• Be aware that surgical masks are not fit-tested to your face and may leave unprotected gaps between the mask and your face.
• Be aware that masks lose their protective properties and must be changed when they become wet from saliva or respiratory secretions.
• Know that surgical masks and surgical N95 respirators are not tested against specific microorganisms and should not claim to prevent specific diseases.
• See CDC recommendations for using surgical masks and surgical N95 respirators in the care of patients needing isolation precautions (Guidelines for Isolation Precautions in Hospitals).
• Never reuse surgical masks or surgical N95 respirators.
• Never wash or disinfect surgical masks or surgical N95 respirators.
• Never share surgical masks or surgical N95 respirators with others.
• See About PPE for information on disposing of surgical masks and surgical N95 respirators.

Find all FDA-cleared surgical masks and surgical N95 respirators

FDA’s website lets you search for medical devices that FDA has cleared or approved, including personal protective equipment.

Search for all FDA-cleared surgical masks

Search for all FDA-cleared surgical N95 respirators

Updated February 28, 2008