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National Institute for
Occupational Safety and Health
(NIOSH) Certification

NIOSH is authorized to approve respirators.

E: info@itbholdingsllc.com

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National Institute for Occupational Safety and Health (NIOSH) Certification

Under the provisions of 42 CFR 84, NIOSH is authorized to approve respirators. The regulatory specifications include performance requirements as well as the criteria for the quality assurance program relevant to manufacturing respirators. In an average year, NIOSH receives approximately 400 requests and grants 250 new approvals.

In the approval process, NIOSH first conducts an initial engineering review to ensure that the request for certification matches all of the accompanying documentation, including product drawings and the quality assurance system specifications.

The product is then sent to the laboratory for testing, and concurrently NIOSH conducts a quality assurance review that delves into the manufacturing processes and procedures. A final review includes comparing the manufacturer’s test results with those obtained by NIOSH’s laboratory and finalizing the labeling, which then leads to an issued approval.

In order to receive a manufacturer’s code, NIOSH/NPPTL (National Personal Protective Technology Laboratory) will need a Manufacturer’s Questionnaire completed and returned by the entity that controls the design or manufacturing of the respirator.

Completed questionnaire must include a photo of the facility showing the company name on the building, a photo of the quality assurance area, and a photo of the production line.

FDA and NIOSH

NIOSH will not issue a certification of a surgical N95 respirator until FDA confirms it is also reviewing the product.

An individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator may apply to NIOSH to become an approval holder.

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.

CONTACT ITB HOLDINGS LLC