Letter to All Respirator Manufacturers
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Issue Date: March 17, 2006
From: Heinz W. Ahlers, Acting Chief, Technology Evaluation Branch, National Personal Protective Technology Laboratory
Subject: Meaning of NIOSH Approval
It has been brought to the attention of NIOSH through phone calls and e-mails from respirator users that some respirator manufacturers may not understand what NIOSH approval actually means. In some instances NIOSH has been notified by these respirator users that manufacturers have claimed that because their company holds one NIOSH approval, every respirator their facility produces is also NIOSH approved.
NIOSH approval is issued only to a specific and complete respirator assembly after the respirator has been evaluated in the laboratory and found to comply with all of the requirements of Title 42, Code of Federal Regulations , Part 84, and after the manufacturer's quality plan is determined to be satisfactory.
A NIOSH approval applies only to the specific respirator that is made up of the components included on the NIOSH approval label. The issuance of an approval number to a respirator manufacturer does not signify that every respirator built within that manufacturer's facility is also NIOSH approved. It also does not allow the manufacturer to modify the respirator in ways that affect form fit or function or to make claims of NIOSH approval for features outside of those approved and certified by NIOSH.
Any respirator manufacturer making false claims such as these may be subject to rescission of all NIOSH approvals held by the manufacturer.