N99 - Mask Comparison

N99 - Side View of Mask

Fitseal FS-400 NIOSH Approved N99 Particulate Respirator Face Masks Additional Information

• FaceSeal Technologies Acrylate Co-Polymer Medical Grade Adhesive - Product Clinical Data Summary

• Q: What is NIOSH (and what do they do)?

  The National Institute for Occupational Safety and Health (NIOSH) is the U.S. Federal Agency responsible for conducting research and making recommendations for the prevention of work-related injuries and illness. NIOSH is part of the CDC (Centers for Disease Control and Prevention) in the Deparmtent of Health and Human Services. NIOSH is responsible for testing and certification of respirators including the 9 types of Filtering Facepiece Particulate Respirators under 42 Code of Federal Regulations (CFR) Part 84. NIOSH approvals are recognized in Canada and many 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 disposable respirators are the first and only strapless adhesion filtering facepiece respirators approved by NIOSH under 42 CFR Part 84 and have undergone additional testing as part of NIOSH certification. Fitseal has been successfully fit-tested by NIOSH in a corn oil atmoshphere to test for inward leakage and the integrity of the respirator-to-face seal.

• Q: How important is the Face-seal?

  Aerosol studies have concluded that particle penetration through gaps between the repirator and the face (the face-seal) can account for over ten times more harmful and toxic particles entering the breathing zone than through the filter media itself. 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, harmful airborne pathogens can enter the wearer's breathing zone.

• Q: What types of particles are Fitseal Respirators effective against?

  The Fitseal Respirators are effective, with their respective NIOSH approvals, against any and all particles. Some examples include: Viruses (SARS, H1N1 or sine flu, H5N1 or bird flu, smallpox, chicken pox), Bacteria (M. Tuberculosis, anthrax), Molds (stachybotris), Laboratory animal allergens (pollens, dust and dust mites, mold, animal fur), Nuisance dust and Industrial hazards (silica, asbestos, grain dust, metallic dust, zinc).

• Q: Are Fitseal Respirators Fluid-Resistant?

  Yes. Fitseal Respirators have been tested for synthetic blood penetration as per ASTM F1862.

• Q: What additional benefits can be achieved by implementing the Fitseal brand of Respirators in the workplace?

  The Fitseal brand of respirators in the workplace will lead to overall cost savings. This can be realized through: Elimination of the need to inventory multiple brands, styles and sizes of conventional respirators; no comples inventory; no stock-outs, Simplifies procurment or respirators; simplified supply chain, User comfort translates into higher levels of productivity in the workplace, reduced absenteeis, due to Occupational illnesses, Reduced time away from work for fit-testing; and a reduction in the cost of fit-testing, and successful fit of individuals who cannot be fitted with conventional banded respirators.

• Q: 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 qualitive fit test when initially assigned to a user and at specified intervals thereafter.

• Q: What is Fit-Testing?

  OSHA mandates fit-testing to ensure that the correct brand/model/size respirator "fits" the wearer's facial contours.

  There are two methods for fit-testing. Qualitative: 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 or denatonium benzoate(Bitrex). Quantitative: 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, a trained technician monitors each individual as they perform numerous maneuvers that imitate work routines. The fit-test procedures are outlined in OSHA Fit-Testing Procedures 1910.134 Appendix A.

• Q: Are Fitseal Respirators effective against Pandemic Flu?

  Yes. Any "flu" virus is a particle, and risk of expisure can be significantly reduced by wearing the Fitseal respirators. The adhesion seal and bi-laterial filtration media helps to protext the user and those around them from contracting or transmitting the flu virus. By minimizing the gaps between the respirator and the face, (the face-seal) the likelihood of further transmission is significantly reduced.

• Q: Why is there no Exhalation-Valve on the Fitseal Respirator?

  Disease-spreading exhalation valves are not required on Fitseal Respirators due to the low breathing resistance of the state-of-the-art filtration media. The breathing resistance on hinhalation and exhalation is significantly less than NIOSH's maximim allowable resistance.

• Q: Do NIOSH approved respirators require CSA approval for use/sale in Canada?

  No. The Canadian Standards Association (CSA) does NOT certify or approve invidual makes, styles or models of repirators for use in Canada. The CSA accepts NIOSH certification or approval of respirators for use in the occupational setting.

• Q: Do Fitseal Respirators require fit-testing?

  Yes. In the U.S. and Canada, OSHA regulations mandate fit-testing for all respirators. Although Fitseal respirators have been approved by NIOSH for one-size-fits-all, they are not exempt from fit-testing.

• Q: 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 fibers per cm, (per Ontartio OSHA), a disposable filtering facepiece respirator can be used.

• Q: Will the adhesive damage the skin after repeated use?

  No. Fitseal respirators meet FDA/ISO Biocompatibility requirements. Extensive testing by leading speacialist in dermatology show 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. The adhesive should not be place over any form of visable dermatitis, scabs, acne or other facial skin infections, open wounds or sensitive skin.

• Q: Can NIOSH approved respirators be used by children?

  No. Respirators are approved by NIOSH according to government performance standards for use by healthy adults who work in an occupational/workplace setting. Fitseal respirators have been designed for adults use only. There are no government performance standards today which specify criteria for desinging or approving respirators for children.

• Q: Why do Fitseal Respirators simplify fit-testing procedures?

  Fitseal Respirators have been approved by NIOSH for one-size-fits-all; fitting a range of facial sizes and shapes from 1 to 10 (one subject from each box of the Los Alamos National Laboratory panel). As such, they will "fit" the vast majority of individuals on the first attempt, reducing mask wasteage and lost time spent testing and re-tested. In addition, changes to a user's facial size due to weight gain/loss or pregnancy will not require re-testing (except as mandated by legislation).

• Q: Do Fitseal respirators provide protection again M.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 criterioa. The NIOSH approved Fitseal Respirators meet the CDC guidelines for use when exposed to M.tuberculosis

• Q: How do Fitseal Respirators improve safety in the workplace?

  1. The Fitseal respirator improves respiratory protection by providing an adhesion seal that markedly reduces the face-seal leakage of disease causing bacteria, viruses, allergens, and toxic particulates. 2. The Fitseal can be applied and removed without removing other protective headgear (glasses, helmets, or hearing protection), Wearer's are not exposed to additional enviromental dangers while donning and doffing the Fitseal respirator. 3. With its state-of-the-art filter media, Fitseal respirators will not move or shift while in use. Wearers can be assured that regardless of their movements, the respirator will remain in place providing reliable respiratory protection. 4. Once applies, the Fitseal respirator will not move or shift while in use. Wearers can be assured that regardless of their movements, the respirator will remain in place providing reliable respiratory protection. 5. Protective eyewear will not fog up. Clear vision through protective eyewear improves safety in the workplace. Users are not exposed to additional enviromental hazards while eyewear is removed to clean off the protective lenses. 6. The Fitseal respirator is puncture, crush, and tear resistant. Prior to donning, it can be folded and placed in your pocket without compromising its effectiveness, or protective ability. 7. Fitseal Respirators do not contain any metal components and are suitable for use in imaging studies, MRI, CT and PET scans.

• Q: What are the 9 types of Filtering Facepiece Particulate Respirators?

  N-series (Not resistant to oils) - tested against midly degrading aerosol of sodium chloride (NaCl) and provides effective filtration of aerosol particulates free of oils. N95 filters at least 95% of airborne particles but is not resistant to oil. N99 filters at least 99% of airborne particles but is not resistant to oil. N100 fileters at least 99.97% of airborne particles but is not resistant to oil.

  R-series (somewhat Resistant to oil) - tested against a highly degrading areosol dioctytphalate (DOP) and provides "somewhat" effective filtration of oil-mist aerosol particulates. R95 filters at least 95% of airborne particles but is somewhat resistant to oil. R99 filter at least 99% of airborne particles but is somewhat resistant to oil. R100 Filters at least 99.97% of airborne particles but is Somewhat resistant to oil.

  P-series (strongly resistant oil proof) - tested against a highly degrading aerosol dioctytphalate (DOP) and provides effective filtration of particulates in an oil-mist/aerosol. P95 filters at least 95% of airborne particles but is strongly resistant to oil. P99 filters at least ((% of airborne particles but is strongly resistant to oil. R100 filters at least 99.97% of airborne particles but is strongly resistant to oil.

• Q: What is a User Seal-Check?

  The user seal check is done by the wearer each and every time after donning a respirator in order to assure that there are no leaks between the repirator and the face (the face-seal). The user seal check in and of itslef does not obviate the fit-test outlined above.

  To ensure a secure repirator-to-face seal, the user seal check consists of breathing in and out forcefully.The top layer of the respirator should billow out slightly on exhalation and collapse inwards on inhalation, indicating that the respirator has a protective seal. Leaks may be detected on breathing in by a slight coolness on the skin at the repirator/skin interface. If the leaks are detected, press firmly around the circumfrence of the Fitseal respirator and then repeat the user seal check.

• Q: What size particles do Fiteseal Respirators filter out?

  Airborne partivles that are considered respiratory hazards range in sizes between 0.01 to 100 micrometers. Fitseal Respirators 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 diamter as per critera in 42 CFR part 84. The partical diameter of 0.3 micrometers 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 electrostatic and mechanical properties of the filter.

• Q: Will perspiration, oily skin, moisturizers and cosmetics affect the adhesion bond to the skin?

  It is important to apply the Fitseal respirator to clean, dry skin free of perspiration, oil, moisturizers, and cosmetics prior to donning to ensure a proper seal to the skin surface.

• Q: Are all Filtering Facepiece Particulate Respirators one-size-fits-all?

  No. There are two classifications of respirators that are designed and constructed to fit users with various facial shapes and sizes:

  Group 1 - Respirators where multiple sizes (small, medium and large) are used to ensure that the respirator will fit a panel of test subjects of various facial sizes and shapes.

  Group 2 - Respirators where a single size (one-size-fits-all) is used to ensure that the respirator will fit a panel of test subjects of various facial sizes and shapes.

  The National Personal Protective Technology Laboratory (NPPTL), Technical Evaluation Branch has developed criteria that must 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 of the 10 subjects, on 2 seperate occasions, is fit-tested in a corn oil atmosphere to test the seal between the respirator and the face (the face-seal). Using the OSHA protocol for Portacount fit-testing, the subjects must collectively pass at least 95% (19 out of 20) of the total trials with an overall fit factor greater than or equal to 100.

  Fitseal Respirators have an overall fit factor greater than or equal to 100 and are approved by NIOSH for one-size-fits-all.

• Q: What is the Fit Factor (FF)?

  The Fit Factor (FF) 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 repirator fit-test procedure(s).

• Q: How will the Fitseal Respirator feel when it is aplpied for the first time?

  Initially, the exhaled air will cause a warm sensation inside the respirator. This is because the respirator does not leak. Unfiltered cool air is not entering your breathing zone by virtue of the effective adhesive face-seal.

  The state-of-the-art filter medium offers extremely low breathing resistance making it easy to breathe with less heat, humidity and Carbon dioxide buildup.

  You will also notice that glasses and protective wear will not fog up. This is because of the adhesion seal that reduces face-seal leakage that will cause the fogging up.

• Q: If the user perspires while wearing the Fitseal Respirator, will it become dislodged?

  No. The Fitseal Respirator will not dislodge due to perspiration; the adhesion face-seal is maintained.

• Q: What is the difference between an N95 and N99 respirator?

  The N95 designation means that the filter medium has a filteration efficiency of at least 95% (i.e. will allow no more than 5% particle penetration) against particles that are 0.3 microns in size. This means that up to 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 filteration efficiency of at least 99% (i.e. will allow no more than 1% particle penetration) against particles that are 0.3 microns in size. This means that up to 1 out of every 100 airborne particles can penetrate the filter medium and enter the wearer's breathing zone.

  It is important to note that while the filter itself will provide certain protection efficiency (95% or 99%) there are other potential sources of particle inward leakage of particles that can reduce a respirators 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 straps and rubber bands to the respirator

• Q: What is the Assigned Protection Factor (APF)?

  The Assigned Protection Factor (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 up to 10 times the Permissible Exposure Limit (PEL) for the particular hazardous agent. The APF values are assigned by U.S. National Standards Organizations such as NIOSH and ANSI.

  It is customary practice to use ten times the APF as the Fit Factor pass level when doing quantitative fit testing. Fitseal Respirators exceed the minimim pass level requirements.

• Q: Do Fitseal Respirators Contain Latex and/or Natural Rubber?

  No. Fitseal Respirators are latex-free and do not contain any natural rubber.

• Q: Can Fitseal Respirators be re-applied?

  All filtering facepiece respirators are disposable and are intended for one time use only.

• Q: 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?

  A result of 5 years of extensive research and development by leading aerosol scientists and medical professionals in Canada and the US, Fitseal strapless adhesion respirators provide unsurpassed respiratory protection, comfort and breathability.

  Made with state-of-the-art filtration media, Fitseal utilizes a medical-grade, hypo-allergenic, latex free adhesion strip to secure the respirator to the face instead of straps, rubber bands, or nose clips. Fitseal is approved by NIOSH for one size fits all and conforms to the countours of your face providing a proper fit and a secure seal, virtually eliminating gaps around the edge of the respirator that can allow inward leakage of harful airborne viruses, bacteria and toxic particles that can get in to your lungs. If the mask leaks, harmful particles can enter the breathing zone, and your health can be compromised.

• Q: What is the Total Inward Leakage (TIL)?

  TIL is the measurement of all routes of particle penetration. This includes particle penetration through the filter material, through exhalation valves, thorugh holes from staples and grommets that attach the straps and rubber bands to the respirator, and through gaps between the respirator and the face (the face-seal).

  The inward leakage of a respirator is determined by measuring thee concentration of a challenge aerosol outside of the respirator, as well as the concentration within the breaking zone. Respirator fit testing normally considers face-seal leakage. Total inward leakage defines a protective level acheived 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)

• Q: Do Fitseal Respirators Contain Metal Components?

  No. Fitseal Respirators are fiberglass-free.

• Q: Where is the Fitseal Respirator Manufactured?

  Fitseal Respirators are manufactured in North America by ISO 9001 approved manufacturing facilites to ensure the highest standard of quality control.