The most important thing to remember about surgical masks is that they are not designed to pass fit tests. (Moldex-Metric photo)

A Comparison of Surgical Masks, Surgical N95 Respirators, and Industrial N95 Respirators

The most important thing to remember about surgical masks is that they are not designed to pass a fit test. Their purpose is to help protect the environment and nearby persons from the wearer's contaminants.

It is easy to confuse a surgical mask, a surgical N95 respirator, and an industrial N95 disposable respirator with one another. They look similar, and the words "respirator" and "mask" are often used interchangeably when discussing respiratory protection. However, in fact there are many differences between them. This article is intended to educate the reader on the differences between surgical masks, surgical N95 respirators, and industrial N95 respirators.

Purpose or Intended Use
Surgical masks

  • May include masks labeled as surgical, laser, isolation, dental, or medical procedure masks
  • Are primarily intended to protect the patient, not the wearer, from the wearer's saliva and respiratory secretions
  • May also help protect the wearer against exposure to microorganisms, body fluids, and large particles in the air but are not tight fitting and likely have substantial inward leakage for particles and organisms
  • Are designed to cover the mouth and nose loosely but are not sized for individual fit
  • Are not NIOSH (National Institute for Occupational Safety and Health) approved

Surgical N95 respirators

  • Surgical N95 respirators are designed to reduce but cannot eliminate the wearer’s exposure to airborne biological contaminants. They do not eliminate the risk of illness, disease, or death.
  • Form a tight seal over the mouth and nose.
  • Require fit-testing and must be adjusted to your face to provide the intended effectiveness of filtering 95 percent of particles with a mass median diameter of 0.3 micrometers.
  • Employers and users are required to follow the OSHA Respiratory Protection Standard, 29CFR 1910.134, as well as other state or local regulations, as appropriate.
  • Have specific use instructions, warnings, and limitations for use in health care environments.
  • Are NIOSH certified.
  • Are fluid resistant to a certified level measured against a stream of artificial blood directed at the respirator.

Industrial N95 respirators

  • Are designed to reduce but cannot eliminate the wearer's exposure against certain airborne particles and aerosols free of oil.
  • Form a tight seal over the mouth and nose.
  • Employers and users are required to follow the OSHA Respiratory Protection Standard, 29CFR 1910.134, as well as other state or local regulations, as appropriate.
  • These respirators (without valves) also can help prevent exhalation of contamination by the wearer to others in the work environment.
  • Require fit-testing and must be adjusted to your face to provide the intended effectiveness of filtering 95 percent of particles with mass median diameter of 0.3 micrometers.
  • Have specific use instructions, warnings, and limitations for use in industrial environments.
  • Are NIOSH certified.
  • Are not certified to be fluid resistant.
  • Approval and Certification
    Surgical masks

    The U.S. Food and Drug Administration (FDA) clears surgical masks for sale in the United States. FDA does not test and certify the respirator. Instead, they clear the respirator for sale after reviewing the manufacturer's test data and proposed claims. The manufacturer performs and submits the results from several tests, including particle filtration efficiency, bacterial filter efficiency, fluid resistance, etc.

    The particulate filter efficiency gives an indication of the quality of the health care surgical mask. However, this rating is completely different and far less rigorous than the NIOSH N95 filter efficiency rating and should not be used as a comparison between the two.

    Surgical N95 respirators
    Surgical N95 respirators are approved by NIOSH as to their respiratory protection efficiency and resistance and other NIOSH requirements. They are also separately cleared by FDA as medical devices. FDA clears surgical masks for sale in the United States but does not test and certify the respirator. Instead, the agency clears the respirator for sale after reviewing the manufacturer's test data and proposed claims. The manufacturer performs and submits the results from several tests, including particle filtration efficiency, bacterial filter efficiency, fluid resistance, etc.

    The biological filter efficiency gives an indication of the quality of the health care surgical mask. However, this rating is completely different and far less rigorous than the NIOSH filter efficiency rating and should not be used as a comparison between the two. Surgical N95 respirators and N95 industrial respirators share the same NIOSH requirements. NIOSH also has other efficiency certification levels for industrial respirators (see below).

    Industrial respirators (including industrial N95 respirators) and Surgical N95 respirators
    In the United States, NIOSH is responsible for testing and certifying respirators to be used in the workplace. NIOSH not only reviews the manufacturer's test data, but also performs its own independent tests on the respirators in NIOSH's governmental laboratories to verify the manufacturer's results. The tests include filter efficiency, degradation, and flow rate, to name a few. In addition to testing the respirators during the submittal process, NIOSH also will periodically purchase respirators in the field and test them to make sure the respirators are performing to their original certification.

    Once the respirator is initially approved, NIOSH will certify its classification as N, R, or P and its filter efficiency as 95 percent, 99 percent, or 99.97 percent. It is also important to note that even though a respirator just by its use often helps to prevent the wearer from contaminating the environment; it cannot be considered a surgical mask unless it has been cleared by the FDA.

    Surgical masks
    The most important thing to remember about surgical masks is that they are not designed to pass a fit test. As explained above, their purpose is to help protect the environment and other nearby persons from the wearer's contaminants. When many surgical masks are worn, they will have gaps around the edges that allow many small particles to enter the respiratory system of the wearer. Even tighter-fitting surgical masks will have some gaps that allow small particles to enter the wearer’s respiratory system.

    Surgical N95 and industrial N95 respirators
    Respirators are designed to seal the respirator to the face and pass a fit test. Under Respiratory Protection Standard 29 CFR 1910.134, the Occupational Safety and Health Administration requires the wearer of a respirator to be fit tested before he or she can use the respirator in a contaminated environment. OSHA also requires the wearer to perform user seal checks on the respirator before each use, as well as comply with the other elements of a comprehensive respiratory protection program in accordance with 29 CFR 1910.134.

    If the wearer is unable to obtain a proper fit, he or she must not enter the contaminated area. For more information on this standard, visit the OSHA website, www.osha.gov.

    A properly fit-tested N95 respirator will greatly reduce the number of small particles that will enter the wearer’s respiratory system, as compared to a surgical mask that is not NIOSH approved. The extent of that reduction is a function of the fit of the mask, its filtration efficiency level (with respirators available from 95 percent to 99.97 percent filter efficiency), and the wearer’s proper donning and wearing of the respirator according to the training the employer provides as required by OSHA regulations.

    Length of Wear
    Surgical masks

    While each facility has its own policy, surgical masks in general are discarded after each procedure. They are typically worn only for specific procedures.

    Surgical N95 and industrial N95 respirators
    Respirators must be put on and taken off in an area outside of the contaminated area. Putting a respirator on or taking it off even for a few seconds in a contaminated area can expose the wearer to significant levels of hazards. Each facility has its own policy on disposal of the respirator, depending on use conditions and the type of hazard that these products are being used to protect against.

    This article originally appeared in the May 2014 issue of Occupational Health & Safety.

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