Regulatory Quest ions
What is NIOSH (and what do they do)?
The National Institute for Occupational Safety and Health (NIOSH) (www.cdc.gov/niosh/about.html) is the USA federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. NIOSH is part of the CDC (Centers for Disease Control and Prevention) in the Department of Health and Human Services and is responsible for the testing and certification of nine types of Filtering Facepiece Particulate Respirators (FFPR’s) under 42 Code of Federal Regulations (CFR) Part 84. NIOSH approvals are recognized in Canada, and other countries worldwide.
Currently, NIOSH certifies filtering facepiece respirators for filter efficiency ONLY. In a letter dated February 27, 2007, the National Personal Protective Technology Laboratory (NPPTL) announced that NIOSH is “…moving forward on plans to develop Total Inward Leakage (TIL) testing as part of respirator certification.”
The Fitseal™ line of respirators are the first and only disposable adhesion filtering facepiece respirators approved by NIOSH under 42 CFR Part 84 and have been fit tested in a corn oil atmosphere to test the integrity of the seal between the respirator and the face (the face-seal).
 
What is OSHA (and what do they do)?
OSHA (Occupational Safety and Health Administration) mandates and enforces health and safety regulations in places of work (occupations). OSHA requires that all respirators be properly fit-tested using a quantitative or qualitative fit test when initially assigned to a user and at regular/stipulated intervals thereafter.
 
Do NIOSH approved respirators require CSA approval for sale in Canada?
No . The Canadian Standards Association (CSA) does NOT certify or approve individual makes, styles or models of respirators for use or sale in Canada. The CSA accepts NIOSH certification or approval of respirators for use in the occupational setting.
 
Technical Questions
What are the nine types of filters and the respective efficiencies?
NIOSH certifies three types of disposable particulate filters with three levels of filter efficiency, 95%, 99% and 99.97%, in each class. All filters are tested by utilizing the most penetrating aerosol size 0.3 micron (aerodynamic mass median diameter).
N-series (Not for oils), tested against a mildly degrading aerosol of sodium chloride (NaCl) and effective filtration of particulates aerosols free of oils
R-series (somewhat Resistant to oil), tested against a highly degrading aerosol dioctytphalate (DOP) and “somewhat” effective filtration of particulates in an oil-mist/aerosol
P - series (strongly resistant oil Proof), tested against a highly degrading aerosol dioctytphalate (DOP) and effective filtration of particulates in an oil-mist/ aerosol
 
Are all filtering facepiece respirators one-size-fits-all?
No . There are two groups of respirators that are designed and constructed to fit persons with various facial shapes and sizes:
Group 1 – Respirators where multiple sizes; small, medium and large, are used to insure that the respirator will fit a panel of test subjects of various facial sizes.
Group 2 – Respirators where a single facepiece is intended to fit a panel of test subjects of various facial sizes; one-size-fits-all.
NIOSH’s National Personal Protective Technology Laboratory (NPPTL) Technical Evaluation Branch has developed specified criteria that need to be met in order to be approved for the one-size-fits-all classification. The NPPTL employs a test panel of 10 subjects with varying facial sizes and shapes classified from size 1 through 10. This is called the Los Alamos National Laboratory (LANL) panel. Each one of these ten (10) subjects, on two (2) separate occasions, is fit-tested in a corn oil atmosphere to test the seal between the respirator and the face (the face-seal). Ten (10) subjects must collectively pass at
least 95% (19 out of 20) of the total trials run with an overall fit factor greater than or equal to 100. The protocol used is per the OSHA method for Portacount fit-testing.
Fitseal™ has an overall fit factor greater than or equal to 100 and is approved by NIOSH for one-size-fits-all. This eliminates the need to procure, re-test and inventory multiple styles, sizes and makes of conventional respirators; therefore, ensuring the appropriate respirator will be available at time of need.
 
What is the difference between an N95 & N99 respirator?
The N95 designation means that the filter medium has a filtration efficiency of at least 95% (i.e. will allow no more than 5% particle penetration) against particles that are 0.3 microns in size. That means that 5 out of every 100 airborne particles can penetrate the filter medium and enter the wearer’s breathing zone.
The N99 designation means that the filter medium has a filtration efficiency of at least 99% (i.e. will allow no more than 1% particle penetration) against particles that are 0.3 microns in size. That means that less than 1 out of every 100 airborne particles can penetrate the filter medium and enter the breathing zone.
It is important to note, that whereas the filter itself will provide certain protection efficiency (95%, 99% or 99.97%), there are other potential sources of particle inward leakage that can reduce a respirator’s effectiveness. These include gaps between the respirator facepiece and the face (the “face-seal”), exhalation valves, and holes from staples and grommets that attach the elastic bands.
 
 
What is the major difference between an adhesion respirator and a conventional respirator that is held in place by straps, rubber bands and nose clips?
Fitseal™ adhesion respirators provide comfort and protection. They fit and they seal.
Studies have shown that a protection level which is derived solely from the filter material may be misleading as it does not take into account particle penetration through gaps between the respirator and
the face (face-seal leakage).
Dr. Sergey Grinshpun, Director of The University of Cincinnati Center for Health Related Aerosol Studies has stated, “For filtering facepiece respirators or surgical masks, particle penetration through face-seal leakage may exceed ten (10) times the particle penetration than through the filter media itself.
Fitseal™ respirators are ONE-SiZE-FITS-ALL and have a medical grade adhesion strip that conforms to the contours of your face eliminating gaps (face-seal leakage) that can allow inward leakage of harmful particles around the edge of the respirator. Once applied, according to user instructions, it will provide a secure and reliable seal, reducing exposure of harmful airborne particles from entering your breathing zone; it will also eliminate glasses and protective eyewear from fogging up and remain in place even during physical activities.
 
How important is the Face-seal?
”Respirators that don’t seal properly around the face offer only the illusion of protection”
Reference: OSHA Technical Manual, Section III
An integral and effective face-seal is extremely important, particularly with exposure to infectious pathogens such as viruses and bacteria. If the respirator facepiece does not seal properly to the face, then harmful airborne pathogens can enter the wearer’s breathing zone. It is therefore essential to carefully follow the donning user instructions and to perform the user seal-check before entering any hazardous environment.
The Fitseal™ line of respirators are the first and only disposable adhesion filtering facepiece respirators approved by NIOSH under 42 CFR Part 84 and have been fit tested in a corn oil atmosphere to test the integrity of the seal between the respirator and the face (the face-seal).
 
What is a Fit-Test?
Fit testing is mandated by OSHA to ensure that the right brand/model/size respirator “fits” the wearer’s facial contours. The individual wears the respirator and a trained practitioner administers the test; either qualitative or quantitative. The qualitative test is a pass/fail that relies on the individual tasting, or not, an administered ambient irritant such as isoamyl acetate (banana oil), smoke, or saccharin (Bitrex). The quantitative test assesses the integrity of the fit (faceseal) by measuring the ratio of an indicator outside and inside the facepiece. In both cases the individual undergoes numerous maneuvers that imitate work routines. The fit-test procedures are outlined in OSHA Fit-Testing Procedures – 1910.134 Appendix A.
 
If a person is fit tested for a particular type of respirator does that mean that the protection level offered is accurate?
When a person is subjected to a quantifiable fit tested (ie: Portacount Test) either ambient particles or particles of sodium chloride are generated. Particle penetration through the respirator filter as well as face-seal leakage depends on particle size and in both cases, the fit test does not discriminate for particle sizes. What this means, is that the fit factor of 100 (representing passage of the fit test) is the measure of penetration (1%) of particles of all sizes generated. It does not necessarily mean that particles of a specific size (e.g. viruses or bacteria) penetrate at the 1% level. The studies conducted using particle size selective instruments have shown that the actual penetration may be much greater than 1% in those cases. The reason primarily relates to the face-seal penetration pathway.
 
Do Fitseal™ respirators require fit testing?
Ye s . In the U.S.A. and Canada, OSHA regulations mandate fit-testing. Fitseal™ is indeed unique, but to date is not yet exempt from fit-testing. Fitseal™ has been approved by NIOSH for one-size-fits-all; fitting a range of facial sizes and shapesfrom 1 to 10 (one subject from each box of the Los Alamos National Laboratory (LANL) panel). As such, they will “fit” the vast majority of individuals on the first attempt, thereby reducing the time spent being fit tested or re-tested; simplifying inventories and supply chains; and ensure that the “right” respirator for that particular individual is available at point of need, when needed. Because Fitseal™ conforms to one’s facial structure; it can successfully fit individuals who could not be fitted with conventional banded respirators.
 
What is a User Seal-Check?
The seal check is done by the wearer each and every time after donning a respirator in order to assure that the respirator is fully “sealed” to the face prior to entering a contaminated work area. The user seal check in and of itself does not obviate the fit-test outlined above.
The check consists of inhaling forcefully once the respirator is donned and seated in the optimal position. Suction should be felt on the inside portion of the facepiece much like when sucking on an empty bottle. The facepiece should partially indent/collapse from the resultant negative pressure thusly generated. If this is not achieved, then press firmly around the circumference of the Fitseal™ respirator to assure that the adhesive fully contact the face, and then repeat the seal check. Repeat the procedure until a proper seal is obtained. If unsuccessful, then discard the respirator and take another.
 
What is the Fit Factor (FF)?
The Fit Factor is a numerical measure of an aerosol challenge expressed as the ratio of the aerosol’s concentration outside the respirator divided by the concentration that penetrated and leaked to the inside during the respirator fit-test procedure(s).
 
What is the Assigned Protection Factor (APF)?
The APF is the level of protection that a particular type of respirator is expected to provide 95% of the time it is used. An APF of 10 means that a properly fitted respirator can be safely used in an atmosphere that has a concentration of up to 10 times the PEL (Permissible Exposure Limit) for the particular hazardous agent. APF values are assigned by national (U.S.A.) standards organizations such as NIOSH and ANSI.
It is customary practice to use ten times the APF as the FF Pass Level when doing quantitative fit testing. The innovative Fitseal™ adhesion respirators exceed the minimum Pass Level requirements.
 
What is Total Inward Leakage (TIL)?
TIL is the measurement of all routes of particle penetration which include; through the filter material, through exhalation valves, staples and gaps between the respirator and the face (the face-seal).
“The inward leakage of a respirator is determined by measuring the concentration of a challenge aerosol outside of the respirator, as well as the concentration within the breathing zone. Respirator fit testing normally considers face-seal leakage. Total inward leakage defines a protective level achieved by a respirator when the contributions of all leakage paths are considered. The TIL is defined as the ratio of the external concentrations to the breathing-zone considered.” (Quoted from the NIOSH Total Inward Leakage Project, October 31, 2007 by Roland Berry Ann)
 
Medical
Fitseal™ Respirators are Effective against which Particles?
The Fitseal™ respirators are effective, consistent with their respective NIOSH certification, against any and all particles. Some examples, but not limited to, are: viruses (SARS, smallpox, chicken pox), pollen, bacteria (TB, anthrax), molds (stachybotris), animal dander (cats), silica, asbestos, metallic dust/fumes, laboratory animal allergens (rats, hamsters), grain dust..
Would Fitseal™ Respirators be Effective against Pandemic Flu?
Yes. Any “flu” virus is a particle, and risk of exposure can be significantly reduced by wearing the Fitseal™respirators. Furthermore, the Fitseal™ respirator with its adhesion seal has been approved by NIOSH for universal fit: one-size-fits-all, and would provide protection even in the absence of fit-testing; something which will be impossible to do for the population at large
during an epidemic or pandemic.
Do Fitseal™ respirators provide protection for asbestos particles?
Yes. According to Ontario Regulations under the Occupational Health and Safety Act, as long as the concentrations are less than or equal to 10 fibres per cm3, a disposable filtering facepiece respirator can be used.
Do Fitseal™ respirators provide protection against Tuberculosis?
Yes. Air-purifying filtering facepiece particulate respirators approved by NIOSH as per 42 CFR Part 84 meet or exceed the CDC filtration efficiency performance criteria. Therefore, the NIOSH approved Fitseal™ respirators meet the CDC guidelines for use when exposed to Mycobacterium tuberculosis.
What Size Particles do Fitseal™ Respirators filter out?
Airborne particles that are considered respiratory hazards range in sizes between 0.01 – 100 micrometers (μm). The Fitseal™ respirator have been tested and proven to filter out such particles with at least 99% efficiency. The established standard for filtration (penetration) is based on testing with particles of 0.3 microns mass median aerodynamic diameter as per criteria in 42CFR Part 84. The particle diameter of 0.3 μm is used because it is the size most likely to penetrate the filter medium. Particles of both smaller and larger diameters will be trapped with even greater efficiency due to the respective electrostatic and mechanical properties of the filter.
 
Comfort and Safety
Why is the Fitseal™ adhesion respirator so effective?
This innovative respirator design eliminates the need for straps, bands, metal nose clips or exhalation valves. It utilizes a medical grade, hypoallergenic, latex-free, fiberglass-free adhesive that is widely used in many medical applications.
 
Approved by NIOSH for one-size-fits-all, you are confident that the respirator will fit. The medical grade adhesion provides a conformable seal between the respirator and the face (the face-seal) which reduces inward leakage and provides a reliable seal even when exerting physical activities.
Fitseal™ is the first and only adhesion filtering facepiece respirator to be approved by NIOSH under 42 CFR Part 84 and fit tested in a corn oil atmosphere to test the integrity of the face seal.
 
How will the Fitseal respirator feel when I put it on for the first time?
Your first feeling will be that of protection and security. Initially, you may feel a warm sensation inside the respirator. That is because the mask does not leak. Unfiltered air is not entering your breathing zone through gaps between the respirator and the face (the face-seal) which is common in most conventional respirators that are held in place by straps, bands and nose clips. The filter media offers extremely low breathing resistance and you should quickly adjust to this feeling. You will also notice that eyewear and protective glasses will not fog up. This is because of the effective adhesion seal that reduces inward leakage that will cause the fogging up. Because the adhesive is pliable and conformable to your facial structure, once applied properly, according to user instructions, the adhesion respirator will provide a comfortable, reliable and secure fit.
 
What is the major difference between an adhesion respirator and a conventional respirator that his held in place by straps, rubber bands and nose clips?
The Fitseal™ difference is found in its comfort and protection.
Latest research by scientists at the University of Cincinnati Center for Health Related Aerosol Studies have concluded that particle penetration through gaps between the respirator and the face (the face-seal) can account for over ten times more harmful and toxic particles entering your breathing zone than through the filter media itself.
Fitseal™ respirators are ONE-SiZE-FITS-ALL and have a medical grade adhesion strip that conforms to the contours of your face eliminating gaps that can allow inward leakage of harmful particles around the edge of the respirator. Once applied, according to user instructions, it will provide a secure and reliable seal it will eliminate glasses and protective eyewear from fogging up and remain in place even during physical activities.
Do Fitseal™ Respirators Contain Latex and/or Natural Rubber?
No. Fitseal™ respirators contain no latex and no natural rubber and are latex-free, fiberglass-free and hypoallergenic.
Will the adhesive damage the skin after repeated use?
This innovative respirator design eliminates the need for straps and utilizes a medical-grade, hypo-allergenic and latex-free adhesive that is widely used in many medical applications. Extensive testing by leading specialists in dermatology at the Institute for Skin Research, Consumer Product Evaluation Branch, has shown that there is no evidence of trauma on the Stratum Corneum barrier, (the upper most layer of the skin) after repeated use. A slight redness or tingling sensation may be felt after removal. As noted in our User Instructions, the adhesive should not be placed over any form of visible dermatitis, scabs, acne or other facial skin infections, open wounds or sensitive skin.
How does Fitseal™ improve safety in the workplace?
1. The Fitseal™ respirator improves respiratory protection by providing an adhesion seal that virtually eliminates the inward leakage of disease causing bacteria, viruses, allergens and toxins.
2. The Fitseal™ respirator can be applied without removing other protective headgear (glasses, helmets, or ear guards), which means that wearer’s are not exposed to environmental dangers. This differs significantly from conventional respirators that require all head gear to be removed in order to apply the mask.
3. There are a significant number of people that are unable to be fit-tested for the appropriate respirator due to the size or shape of their face, leaving them either exposed or unable to properly do their jobs. Fitseal™ is the first and only One-Size-Fits-All conformable disposal adhesion respirator in the world approved by NIOSH.
4. Fitseal™ with its state-of-the-art filter media provides clear communication and speech recognition. This means that you do not have to remove the respirator to be heard and possibily exposing yourself to bio/environmental dangers.
5. Once applied according to user instructions, the Fitseal™ respirator will not move or shift on your face. The medical grade adhesion seal means that wearers can be assured that regardless of their movements, the mask will remain in place providing unsurpassed respiratory protection.
6. The Fitseal™ respirator is puncture, crush, and tear resistant. It can be folded and placed in your pocket without worry of compromising its effectiveness and protective ability.
7. Fitseal™ respirators do not contain any metal components and are suitable for use in imaging studies, MRI, CT and PET scans.
Can I re-apply the Fitseal™ respirators?
All filtering facepiece respirators are disposable and for one time use only. Fitseal™ respirator CAN be re-used in terms of its mechanical function; the filter will work and so will the adhesive. The question is not whether it “can” be re-used, but rather whether it “should” be re-used; and that is a matter of proper policy and good practice. It is up to the organization or the individual to make that decision. User seal-checks will confirm a good “face-seal” but obviously manufacturers cannot warranty such practices.
 
Market Segments and Appl icat ions
The Fitseal™ N99 and P100 adhesion respirators provide enhanced respiratory protection for those who want more effective and reliable protection than that offered by conventional respirators that are held in place by straps, rubber bands and nose clips.
 
 
Fi rst Responders
Emergency Medical Services
Firefighters
Police
 
Heal thcare
Hospitals
Medical Clinics
Critical Care Facilities
Dental Clinics
Home Healthcare
Veterinary
Coroner/Mortuary
 
 
Indus t r ial
Manufacturing
Construction/Demolition
Laboratories
Agricultural/Farming
Financial Institutions
Transportation
Public Utilities
Oil & Gas
Food Services
Pharmaceutical
Manufacturing
Mining
Hazardous Waste Clean-up
Courier Services
Postal Service
Airlines
 
Emergency
Preparedness
Pandemic Preparedness
Humanitarian Relief
Bioterrorism
Disaster Recovery
Hotel & Office Tower
Evacuation
Essential Services
 
Government
Agencies
Military
Homeland Security
Border Security
Customs & Immigration
Officers
Educational Institutions
 
Consumer
Travelers (business/personal)
Gardening & Landscaping
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