Get your product NIOSH-Approved : You sell the product while we take care of the paperwork for you​
​
Getting a particulate respirator approved by NIOSH requires much work and preparation. Each company that manufactures NIOSH-approved respirators has done a lot of work to develop its respirators, earn NIOSH approval, manufacture and sell these respirators, and continually maintain their quality to remain NIOSH-approved. The specific code manufacturers comply with for NIOSH approval is Code of Federal Regulations 42 part 84, commonly called 42 CFR 84.
​
Assuming the manufacturer has completed all the design and development work and is ready to apply for NIOSH approval, the company must prepare an extensive package for NIOSH. This includes various performance tests, drawings, packaging and label copy, detailed user instructions, a product quality plan, and a quality assurance manual for its manufacturing facility.
​
We can help you prepare all the documentation, while you only focus on marketing the product.
​
Once the manufacturer receives approval, it can begin to market the respirator. Changes cannot be made to the manufacturing process that would change the performance of the respirator in any way from the way it was originally submitted to NIOSH. Each manufacturer is subject to onsite and field audits by NIOSH. During a field audit, NIOSH purchases respirators in the field and tests them in their government laboratory. If NIOSH finds any inconsistencies on-site or in the field, they can ask the manufacturer to make a correction, stop selling the product and recall existing product from the field.
​
All these regulations and requirements are designed to ensure the safety of the public when using these respiratory products. However, the employers and end users also must share responsibility by ensuring the respirators are used in accordance with OSHA regulations and the manufacturer's instructions, that they fit properly, and that they are not misused or abused.
​
