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March 2010

NIOSH Issues User Advisory Notice for Four Champak N95 Respirators

The National Institute for Occupational Safety and Health (NIOSH) has issued a user advisory notice for NIOSH-certified N95 respirators with the following approval numbers: TC-84A-4363, TC-84A-4364, TC-84A-4394 and TC-84A-4665, produced by Champak Enterprise Co., Ltd before February 2010 may, in limited situations, not meet the filtration efficiency requirements specified in Title 42, Code of Federal Regulations, Part 84 due to faults in internal testing procedures.  Please discontinue use of these products until further notice. 

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For public and hospital use, many have suggested N-95 respirators. The IAFF does not believe that this type of respirator will afford fire fighter and emergency medical personnel proper protection. Accordingly, the IAFF recommends that emergency responders use, at a minimum, a P-100 respirator.

The IAFF’s P-100 filter efficiency recommendation is consistent with NIOSH recommendations for emergency response to biological agent incidents:

Additionally the IAFF's recommendation is consistent with federal OSHA regulations that state “where workers are exposed to a hazard that would require the use of a respirator with HEPA filtration, the appropriate class of respirator under the 42 CFR Part 84 certification is the Type 100 (N-100, R-100, or P- 100).” The IAFF recommendation is also consistent with the specifications contained in the World Health Organization’s Hospital Infection Control Guidance for SARS.

Additionally, disposable respirators must have seal enhancing elastomeric components (e.g. rubber or plastic respirator to face seals) and must be equipped with two or more adjustable suspension straps. The IAFF believes, and research has demonstrated, that without these components it is difficult, if not impossible, to obtain and maintain a seal in the workplace. All disposable respirators, as well as APRs and PAPRs, must also be certified by the National Institute for Occupational Safety and Health (NIOSH). NIOSH-approved disposable respirators are marked with the manufacturer’s name, the part number (P/N), the level of protection provided by the filter (e.g., P-100), and “NIOSH.” This information is printed on the facepiece, exhalation valve cover, or head straps. If a NIOSH marking is not on the respirator, it is not certified by NIOSH and should not be used.


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