overview

A comparison of Surgical Masks, Surgical N95 Respirators & Industrial P2Respirators

It is easy to confuse a surgical mask, healthcare surgical N95 respirator (which Moldex sells in Australia and New Zealand, but is P2 compliant) and an industrial P2 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 P2 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.
  
  These do not meet AS/NZS 1716 or U.S. NIOSH regulations.

Moldex^® does not manufacture surgical masks.

Surgical N95 Respirators

• Masks 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 should follow the Australian Standard AS/NZS 1715 “Selection, use and maintenance of respiratory protective devices” and requires that respiratory protecton used by the wearer be fit tested prior to issue and then at least annually, thereafter, or sooner if, for example, facial characteristics or other changes occur which may effect fit.
  
• Have specific use instructions, warnings and limitations for use in healthcare environments.
  
• Are NIOSH certified, but also meet P2 requirements set forth by AS/NZS 1716 2012.

Industrial N95 Respirators

• Are designed to reduce but cannot eliminate the wearer’s exposure against certain airborne particles and aerosols.
  
• Form a tight seal over the mouth and nose. Employers & users should follow the guidance as set forth in AS/NZS 1715-2009 including performance of a fit test deemed suitable for particulate respirators. 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. They should be fit tested prior to issue and then at least annually, thereafter, or if facial characteristics or other changes occur which may effect fit. Suitable fit testing procedures are provided in AS/NZS 1715 2009. Qualitative fit tests such as saccharin mist or a quantitative fit test method such as Portacount may be used for the fit testing of these respirators.
  
• Have specific use instructions, warnings and limitations for use in industrial environments.
  
• Are certified in accordance with AS/NZS 1716 2012.

Approval and Certification

Surgical Masks

Surgical masks sold in this region may meet AS 4381, but do not necessarily have adequate filtering efficiencies or fit to provide the level of protection that an N95 or P2 respirator is designed to meet. These masks are generally designed to prevent contamination by the wearer, from sputum or mucous to the patient or an uncontaminated area. They also may provide the wearer with a limited amount of protection from sprays, splashes, blood, or body fluids from entering the wearer’s breathing zone. They are not designed to offer the level of protection that a properly fitted and worn N95 or P2 respirator is designed for.

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). These N95 respirators are P2 compliant..

Industrial P2 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, filter degradation, and resistance at a certain 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.

In Australia, Standards Australia is responsible for establishing technical and regulatory requirements for respirators to be used in the workplace. Independent agencies, such as SAI, are approved by Standards Australia to review and certify respirators to the AS/NZS 1716 standard. Certified P2 respirators must be tested by approved labs to assure they meet all specified requirements such as filtration efficiency (96%), breathing resistance, flammability etc. Manufacturer’s facilities are audited annually on-site to assure adequacy of the quality controls and management systems. SAI certifies Moldex P2 respirators prior to introduction in the marketplace and lists them on their website. This, in turn, allows the product to bear the SAI Standardsmark logo attesting to its compliance with the AS/NZS 1716 standard.

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 P2 Respirators

Respirators are designed to seal the respirator to the face and pass a fit test.
AS/NZS 1715-2009 provides guidance on performance of a fit test deemed suitable for particulate respirators.
They should be fit tested prior to issue and then at least annually, thereafter, or if facial characteristics or other changes occur which may affect fit. Suitable fit testing procedures are in the standard. Qualitative fit tests such as saccharin mist or a quantitative fit test method such as Portacount may be used for the fit testing of these respirators.
• The wearer of a respirator should be fit tested before they can use the respirator in a contaminated environment. AS/NZS 1715 2009 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.. 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 igs.nigc.ir/IGS/OTHER/NZS-1715.PDF. A properly fit tested N95 or P2 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 or Standards Australia approved. The extent of that reduction is a function of the fit of the mask, its filtration efficiency level (with NIOSH certified respirators available from 95% to 99.97%, and AS/NZS 1716 respirators from 80% to 99.95% filter efficiency. Note that Moldex does not market P1 respirators) and the wearer’s proper donning and wearing of the Respirator according to the training the employer provides as required.

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 P2 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^® & Inovel^® has a series of products that are P2 CERTIFIED. We also sell NIOSH certified and FDA cleared products making these both a respirator and surgical mask. These products can be used throughout the healthcare facility, where appropriateness has been determined by a healthcare professional, 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: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/PersonalProtectiveEquipment/ucm055977.htm

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

Moldex Surgical N95 & Industrial Respirators: http://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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