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NIOSH Approval FAQs
The NIOSH National Personal Protective Technology Laboratory (NPPTL) Respirator Approval Program is responsible for evaluating and approving respirators for use within U.S. workplace settings. NPPTL certifies that all respirator models meet the minimum construction, performance, and respiratory protection standards.
When a respirator has been approved by NIOSH, you can be confident that the device will provide the expected level of protection, as long as a fit test determines that the respirator fits your face and you wear it correctly.
For more information, view the NIOSH CA 2019-1012, NIOSH Respirator Approval Contents and Meaning.
For those interested in pursuing NIOSH approval, NIOSH maintains a dedicated webpage for respirator manufacturers or applicants. This Respirator Approval Information webpage provides interested parties with information about the NIOSH approval process. NIOSH has standard application procedures for each respirator type that outlines the approval process and steps that applicants need to take to achieve NIOSH approval.
During normal operations, the total time from start to finish can range from one month to nine months depending on application issues and any non-conformances identified during the application review or initial site visit.
NIOSH approval fees are available in the standard application procedures and the Respirator Certification Fees Final Rule.
No. NIOSH does not recognize any respiratory protection devices claiming to meet international standards as conforming to NIOSH requirements.
No. NIOSH only approves respirators in accordance with 42 Code of Federal Regulations Part 84external icon. NIOSH does not approve or certify other PPE items (e.g., gowns, gloves, face shields). The U.S. Food and Drug Administration (FDA)external icon clears medical masks and other types of PPE for use in healthcare settings.
No. NIOSH does not approve independent third-party testing laboratories, nor does NIOSH endorse any third-party laboratories. NIOSH is not an accreditation body and does not accredit independent third-party testing laboratories.
No. NIOSH does not sell respirators or any other types of personal protective equipment (PPE). NIOSH cannot recommend specific manufacturers or a specific model for purchasing decisions. Additionally, NIOSH does not keep a list of retailers that sell respirators.
Identifying NIOSH-approved Respirators
The markings on the respirator and NIOSH approval label are key to helping you identify a NIOSH-approved respirator. All NIOSH-approved respirators have a testing and certification (TC) approval number (e.g., TC 84A-XXXX). The NIOSH approval label, which is found on or within the respirator packaging indicates the TC approval number as well as protection type. You can verify that your respirator approvals are valid by checking the NIOSH Certified Equipment List (CEL). If you have a filtering facepiece respirator (FFR), make sure all the required approval markingspdf icon are on the respirator.
You can search for NIOSH-approved respirators on the NIOSH Certified Equipment List, which is the official listing of all NIOSH-approved respirators. If you are looking for a filtering facepiece respirator, you can also refer to the approved table listings of NIOSH-Approved Particulate Filtering Facepiece Respirators.
If you search a NIOSH TC approval number (e.g., TC 84A-XXXX) and no results appear within the CEL, that means it is not a valid approval number and the product is not NIOSH approved.
Most valid NIOSH-approved N95 respirators will have two headband straps, not ear loops. However, a few NIOSH-approved models are approved with ear loops because the loops are secured behind the head with a non-removable fastener.
A private label is when a company enters into an agreement with a NIOSH approval holder and obtains permission to package the product under the private label holder’s name using the same TC approval number as that held by the approval holder (e.g., TC 84A-XXXX). No modifications are made to the respirator except for changing the name on the packaging and on the user instructions. You can verify that a private label holder is valid by searching the NIOSH Certified Equipment List.
When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, the respirators are posted on the Counterfeit Respirators/Misrepresentation of NIOSH Approval webpage to alert users, purchasers, and manufacturers.
Before reporting a counterfeit respirator to NIOSH, you should first verify the identified respirator is counterfeit or misrepresenting a NIOSH approval by looking up the TC approval number (e.g., TC 84A-XXXX) on the NIOSH Certified Equipment List and verifying the required approval markingspdf icon. Then check the Counterfeit Respirators/Misrepresentation of NIOSH Approval webpage to see if that respirator is listed. If not, you may send an email to PPEConcerns@cdc.gov with details about the respirator. If possible, include photos of the respirator and package with your submission.