The New Name in Advanced Filtering Face piece Respirators

What makes Fitseal™ the most revolutionary advancement in filtering face piece respirators?

The Fitseal™ respirator is the first and only adhesion filtering face piece respirator approved by NIOSH* under 42 CFR part 84, and that has met the additional test requirements for new technology as part of respirator certification.

The patent pending Fitseal™ conformable adhesion technology offers a universal fit: and approved by NIOSH for one-size-fits all.

It’s unique design and adhesion technology forms an adhesion seal between the respirator and the face (the face-seal) minimizing the problems of hazardous inward leakage between the respirator and the face common to conventional respirator designs that are held in place by straps or rubber bands.

It’s state-of-the-art filtration material offers extremely high filter efficiency and extremely low breathing resistance

*NIOSH currently certifies filtering face piece particulate respirators (FFPR) for filter efficiency only under Subpart K of Title 42, Code of Federal Regulations, Part 84
(42 CFR84)

"Respirators that don’t seal properly around the face offer only the illusion of protection.”
- OSHA Technical Manual, Section VIII

Studies have shown that without a proper seal, it is possible that up to an additional 10% of unfiltered airborne particles can by-pass the respirator through gaps between the respirator and the face (the face-seal). Additionally, there can be other sites of leakage such as exhalation valves, and the perforations from staples and rivets that are used to attach the bands to the filter. For this reason, NIOSH has called on manufacturers to engineer innovative designs for better fit that address all routes of particle leakage.

The NPPTL, in a Letter to all Interested Parties, dated February 27, 2007
has announced that it is moving forward on plans to develop Total Inward Leakage (TIL) testing as part of respirator certification.

The NPPTL, in a Letter to All Respirator Manufacturers, dated March 10, 2009; “Approval of Filtering Face piece Respirators with Novel Head Suspensions Systems” has stated that historically, it has not accepted alternative head suspension systems for filtering face piece respirators. NIOSH has now revisited this policy and believes that newer materials and technologies may result in novel head harness suspension designs that are capable of providing and maintaining a good fit during use. As a requirement for new material and technology certification, NIOSH has implemented additional test requirements consisting of a fit test done in generated corn oil atmosphere.

This represents a radical change to filtering face piece respirator certification. This initiative acknowledges that the level of protection provided by conventional banded respirators may be suboptimal if the respirator does not seal properly around the face, even with proper fit testing.

“Face-seal leakage is the weak link that limits a respirator’s protection ability”*

*Reference: Mortality Week Report, December 30, 2005/54 (RR17); 1-141, entitled “Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005”, Section: Effectiveness of Respiratory-Protection Devices: Face-seal leakage.

What is Total Inward Leakage (TIL)?

• Total Inward Leakage (TIL) is the measurement of all possible routes of particle penetration which include; through the filter medium, through an exhalation valve and gaps between the respirator and the face (the face-seal).State-of-the-Art Filtration Material and Adhesion
• Advanced, two way multi-layered filtration medium to capture toxic, allergenic and infectious airborne particles
• Extremely low particle penetration of 0.3 micron-sized particles at an airflow rate of 85 L/min
• Meets CDC guidelines for M. tuberculosis exposure control
• Minimal heat, CO2 and humidity accumulation
• Puncture, crush, tear resistant
• Fluid & Fire resistant
• No exhalation valve required
• Easy to breathe and communicate through
• Hypoallergenic, latex-free and fiberglass-free
• Medical grade adhesion commonly used in medical applications
• Can be worn for up to 8 hours

Universal Fit: One-Size-Fits-All

• Readily conforms to most facial contours
• Eliminates the need to procure, re-test and inventory multiple styles, sizes and makes of conventional respirators
• Assures availability at time of need
• Simplifies fit testing procedures (reduces time and cost)

Unique Design and Shape

• Approved by NIOSH for one-size-fits-all
• Large inner surface area allows for easy of breathing and talking
• Offers a custom facial fit and can even be worn upside down
• Designed and engineered to fit the general population
• Application does not interfere with headgear
• Reduces fogging of glasses and other protective eyewear
• Flat design for compact packaging and portability
• Adhesion seal is maintained when talking, coughing and even during physical activity

Scientifically Tested and Validated

• The results of 5 years of advanced research and development by world renowned aerosol scientists at leading Universities and research laboratories
• Medical grade adhesion tested by leading dermatologists show no damage or irritation to the skin even after repeated use
• Manufactured in the USA under strictly regulated ISO 9000 quality control standards

FEATURES & BENEFITS SUMMARY

• UNSURPASSED RESPIRATORY RISK REDUCTION AND PROTECTION
• UNIVERSAL FIT: ONE-SIZE-FITS-ALL
• MOLDS TO MOST FACIAL SHAPES & SIZES
• DESIGNED TO FIT THE GENERAL POPULATION
• MEETS CDC GUIDELINES FOR M. TUBERCULOSIS EXPOSURE CONTROL
• CAN EVEN BE WORN UPSIDE DOWN• NO PRESSURE POINTS (BANDS, NOSECLIPS OR STAPLES)
• COMFORTABLE TO WEAR, EASY TO BREATHE
• GOOD SPEECH RECOGNITION & COMMUNICATION
• DOES NOT INTERFERE WITH HEADGEAR
• REDUCES FOGGING OF PROTECTIVE EYEWEAR
• DURABLE; PUCTURE, CRUSH, TEAR RESISTANT
• MOISTURE AND FLAME RESISTANT
• USES MEDICAL GRADE ADHESION TO FORM AN EFFECTIVE FACE-SEAL
• RELIABLE & SECURE FIT MAINTAINED EVEN DURING PHYSICAL ACTIVITIES
• DISPOSABLE, CAN BE WORN FOR UP TO 8 HOURS
• MANUFACTURED IN THE U.S.A. UNDER ISO 9000 QUALITY STANDARDS

Fitseal™ Specifications:

• Low inhalation and exhalation resistance
• Viral Filtration Efficiency (VFE) greater than 99.9%
• Bacterial Filtration Efficiency (BFE) greater than 99.9%
• Synthetic Blood Penetration (ASTM F1862) - none observed in 32 samples
• Flammability (FDA 16 CFR Part 1610 Class 1) – no flame spread
• Hypoallergenic, latex-free & fiberglass-free
• Overall Fit Factor (FF) greater than 100
• Assigned Protection Fact (APF) of 10