ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
NIOSH
Certified
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 CERTIFICATION

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.
$350.00 SERVICE FEE

NIOSH User Fees are extra and required.

FDA UPDATES

Early in the public health emergency, there was a need to issue emergency use authorizations (EUAs) for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators.

Since the beginning of the pandemic, NIOSH has approved more than 875 respirator models or configurations, with some of these manufactured by approximately 20 new, domestic NIOSH-approval holders. There are more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list which have met the NIOSH-approved EUA criteria and thus are FDA-authorized. These include:

  • 600 filtering facepiece respirator (FFR) models (of which there are over 530 N95 FFR models)
  • 5,500 elastomeric respirator configurations, including new elastomeric respirators without an exhalation valve
  • 360 powered air purifying respirator configurations

Today, those conditions no longer exist because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. As a result, the FDA revoked Emergency Use Authorizations (EUAs) of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, which includes imported disposable respirators such as N95s and KN95s.

Occupational Safety and Health Administration’s (OSHA) recently published Emergency Temporary Standard (ETS) requires health care employers to provide NIOSH-approved or FDA-authorized respirators.

Therefore, domestic and foreign companies need to stop importing or exporting non-NIOSH-approved respirators.

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