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Nor does the inclusion of the donning procedure or user instructions included on the website and PDF versions. These links do not constitute an endorsement of their content, or a statement of NIOSH policy. These NIOSH-approved surgical N95 respirators are only on the Certified Equipment List (CEL).ĭisclaimer: The links in this section go to websites outside of CDC/NIOSH.
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Surgical N95 respirators approved under the MOU do not require FDA’s 510(k) clearance. Also contact the FDA Center for Devices and Radiological Health at 1-80 to verify its clearance. If you believe a surgical N95 respirator is missing from the list, contact the CDC to determine the respirator’s approval status. NIOSH also provides a table of the surgical N95 respirators approved prior to the MOU. The Model Number/Product Line in bold text followed by (FDA) indicates these surgical N95 respirators in the table below. Prior to this MOU, both NIOSH and FDA approved and cleared surgical N95s. This MOU granted NIOSH the authority to approve surgical N95 filtering facepiece respirators. NIOSH entered a Memorandum of Understanding external icon (MOU) in 2018 with the Food and Drug Administration (FDA). See the Notes section for information about private labels. Web links in the table go to the NIOSH Approval Holder’s website. You can find a specific manufacturer by clicking on the first letter of their name on the index below. This web page provides a table of NIOSH-approved N95 respirators listed by manufacturer from A-Z. This product filters at least 95% of airborne particles but is not resistant to oil-based particles. The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators.