Difference between Respirators and Surgical Masks

Because certain disposable respirators are similar in appearance to many surgical/procedure masks, their differences are not always well understood. However, respirators and surgical masks are very different in intended use, fit against the face, wear time, testing and approval. The purpose of this document is to highlight some of these difference, especially those who are intending to take this industries need to take good attention for their difference for your choice of surgical masks and respirators material.

1.Intend use: The biggest difference between a respirator and a surgical mask is the intended use.

Respirators: are designed to help reduce the wearer’s respiratory exposure to airborne contaminants such as particles, gases or vapors. Particulate respirators may be used to reduce exposure to particles that are small enough to be inhaled - particles less than 100 microns (μm) in size. This includes airborne particles that may contain biological material, e.g. mold, Bacillus anthracis, Mycobacterium tuberculosis, the virus that causes Severe Acute Respiratory Syndrome (SARS), influenza, etc.

Surgical masks: do not have either adequate filtering or fitting attributes to provide respiratory protection for the wearer. They are designed to help prevent contamination of the work environment or sterile field from large particles generated by the wearer (e.g. spit, mucous). Surgical masks may also be used to help reduce the risk of splashes or sprays of blood, body fluids, secretions and excretions from reaching the wearer’s mouth and nose.

2.Fit: Fit against the face is also an important differentiator.

Respirators: such as N95 filtering face pieces are designed to seal to the face of the wearer. Therefore most of the inhaled air is drawn through the filter media and not through gaps between the respirator and the wearer’s face. To determine proper fit, wearers must be fit tested to make sure they have selected the appropriate model and size. The wearer must also perform a ‘”user seal check” each time the respirator is worn prior to entering the contaminated environment to check the respirator-to-face seal.

Surgical masks: are not designed to seal against the face and are not fit tested since the main goal is to help capture large particles expelled by the wearer and to help reduce the wearer’s exposure to splashes. During inhalation, much of the air passes through gaps between the face and the surgical mask.

3.Wear Time

Respirators must be carefully donned and worn properly the entire time the wearer is in the contaminated area.

Surgical masks are frequently worn for specific procedures and then removed.

4.Approval/Certification: Government requirements for testing and certifying respirators and surgical masks are substantially different.

Respirators must be tested and certified by the National Institute for Occupational Safety and Health (NIOSH). NIOSH tests particulate respirators under “worst case” conditions to help ensure adequate performance in the work place. The test protocol includes high flow rate, most penetrating particle size, aerosols that may degrade filter material, etc.

Filtering facepiece respirators that are approved under these tests must have “NIOSH” and the filter classification printed on them.

The Food and Drug Administration (FDA) does not test surgical masks. Rather, the manufacturer provides data and proposed claims to FDA for review. The FDA reviews manufacturer’s test data and “clears” the mask for sale.

5.Test: Tests include particle filtration efficiency (PFE), bacterial filtration efficiency, fluid resistance, flammability testing, etc.

The results of the surgical mask PFE testing and the NIOSH filtration testing should not be compared. The PFE test is a quality indicator for healthcare surgical masks. The PFE test is not an indicator of respirator protection performance and is not comparable to the government mandated filtration testing required for NIOSH approved respirators, such as the N95 filtering facepiece respirator.

The filter media of a surgical mask with a very high PFE (>95%) may be less than 70% efficient when tested with the NIOSH N95 test method. Additionally, because surgical masks do not seal against the face when worn much of the inhaled air passes through gaps between the mask and the face rather than through the filter media. The bacterial filtration efficiency and fluid resistance tests measure the masks ability to capture large particles expelled by the wearer and to help reduce the wearer’s exposure to splashes respectively.

In conclusion, surgical masks in effect put a barrier between the wearer and the work environment or sterile field. They may help keep spit and mucous generated by the wearer from reaching a patient or medical equipment. They can also be used as a fluid barrier to help keep blood splatter from reaching the wearer’s mouth and nose. However, surgical masks cannot provide respiratory protection unless they are also designed, tested and NIOSH approved as a respirator. If a wearer wants to reduce inhalation of smaller, inhalable particles (those smaller than 100 microns),they need to obtain and properly use a NIOSH-certified respirator. If the wearer needs a combination surgical mask and a particulate respirator, they should use a product that is both cleared by FDA as a surgical mask and tested by NIOSH as a particulate respirator.

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