- Each application for approval must contain a complete written description of the respirator for which approval is requested, together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used.
- Drawings must be titled, numbered, and dated.
- Proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part.
- A statement that the respirator has been pretested by the applicant as prescribed in § 84.64, and must include the results of such tests.
- A statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing.
- Organizations may appoint an authorized representative to complete and submit the Standard Application Form (SAF) to NIOSH.
- Prospective approval holders, who have received a three character manufacturer’s code, may submit an initial application for a single new respirator along with a signed and approved company Quality Assurance (QA) Manual.
Respirator Certification User Fees
|Fee type||Legal citation||Amount||Due date|
|Application||42 CFR 84.20(b)(1)||$200 per application submitted.||Upon receipt of any application request.|
|Approval||42 CFR 84.20(b)(1)||$100 per each certificate of approval issued.||Upon completion of the application and granting of an approval number.|
|Approval Modification||42 CFR 84.20(b)(1)||$50 per each certificate of approval modified.||Upon completion of the application and issuing a modified approval.|
|Site Qualification||42 CFR 84.20(b)(3)||Upon agreement on the date of the site qualification examination.|
NIOSH other User Fees are related to products testing.
NIOSH-approved filtering facepiece respirators (FFRs) will always have one of the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.
Signs that a respirator may be counterfeit:
- No markings at all on the filtering facepiece respirator
- No approval (TC) number on filtering facepiece respirator or headband
- No NIOSH markings
- NIOSH spelled incorrectly
- Presence of decorative fabric or other decorative add-ons (e.g., sequins)
- Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
- Filtering facepiece respirator has ear loops instead of headbands
Any misuse of NIOSH marks, including on respirators that have failed to satisfy NIOSH’s regulatory requirements or have not received a NIOSH approval, is a direct violation of trademark laws.