Comparison of Respirators and Surgical Masks

SUBJECT: A COMPARISON OF SURGICAL MASKS, SURGICAL N95 RESPIRATORS & INDUSTRIAL N95 RESPIRATORS
ORGIN: Moldex Technical Services Department
DATE: July 2007
REVIEWED: July 2015

Overview

A comparison of Surgical Masks, Surgical N95 Respirators & Industrial N95 Respirators

It is easy to confuse a surgical mask, surgical N95 respirator and industrial N95 disposable respirator with each other. They look similar and the use of the word “respirator” and “mask” are often used interchangeably when discussing respiratory protection. However, there are in fact many differences between them. This document is intended to educate the reader on the differences between surgical masks, Moldex® surgical N95 respirators and Moldex® Industrial N95 respirators.

Purpose Or Intended Use

Surgical Masks

  • May include masks labeled as surgical, laser, isolation, dental, or medical procedure masks.
  • May help protect against exposure to microorganisms, body fluids, and large particles in the air.
  • Are designed to cover the mouth and nose loosely, but are not sized for individual fit.
  • May help prevent exposure of patients to the wearer’s saliva and respiratory secretions.
  • Are not NIOSH (National Institute for Occupational Safety and Health) approved.

Surgical Masks

  • 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.
  • Employers and users are required to follow the OSHA Respiratory Protection Standard, 29CFR 1910.134.
  • Have specific use instructions, warnings and limitations for use in healthcare environments.
  • Are NIOSH certified.

          All Moldex Healthcare Respirators Are NIOSH Approved And Have Been Cleared By FDA And Therefore Have An N95/Surgical Mask Approval

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 & users are required to follow the OSHA Respiratory Protection Standard, 29CFR 1910.134.
  • These respirators (without valves) can also 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.
  • Have specific use instructions, warnings and limitations for use in industrial environments.
  • Are NIOSH certified.

Approval And Certification

Surgical Masks

The Federal Drug Administration (FDA) clears surgical masks for sale in the United States. The 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 healthcare surgical mask. However, this rating is completely different than the National Institute for Occupational Safety and Health (NIOSH) 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 a medical device. The Federal Drug Administration (FDA) clears surgical masks for sale in the United States. The 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 biological filter efficiency gives an indication of the quality of the healthcare surgical mask. However, this rating is completely different than the National Institute for Occupational Safety and Health (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 their own independent tests on the respirators in their 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 will also periodically purchase the respirators in the field and test them to make sure the respirator is performing to its original certification. Once the respirator is initially approved, NIOSH will certify its classification as N, R or P and its filter efficiency as 95%, 99%, or 99.97%. 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.

Fit

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 most 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 many small particles to enter the wearer’s respiratory system.

Surgical N95 & 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 (OSHA) requires the wearer of a respirator to be fit tested before they 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, they must not enter the contaminated area. For more information on this standard, please visit the OSHA website at www.osha.gov. A properly fit tested N95 Respirator will greatly reduce the number of small particles which 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% to 99.97% 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 a different policy, surgical masks in general are discarded after each procedure. They are typically worn only for specific procedures.

Surgical N95 & 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 a different policy on disposal of the respirator depending on use conditions and the type of hazard that these products are being used to protect against.

Moldex Solution

Moldex® has a series of products that are both NIOSH certified and FDA cleared making these products a respirator and surgical mask. These products can be used throughout the healthcare facility to help reduce but not eliminate the wearer’s exposure to the spread of dangerous airborne pathogens. They also have the highest level of fluid resistance available. For more information on these products call (800) 421-0668, ext. 512/550.

Reference

NIOSH Certified Equipment List: http://www2a.cdc.gov/drds/cel/cel_form_code.asp
FDA Masks & N95 Respirators: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/PersonalProtectiveEquipment/ucm055977.htm

OSHA Respiratory Protection Standard, 29CFR 1910.134: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=12716&p_table=standards

Moldex Surgical N95 & Industrial Respirators: https://www.moldex.com/respiratory-protection/disposable-respirators/index.php

WARNING: The information contained in this Tech Brief is dated and was accurate to the best of Moldex’s knowledge, on the date above. It is not meant to be comprehensive, nor is it intended to be used in place of the warning/use instructions that accompany Moldex respirators.

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