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The Importance of Checking for NIOSH Certification

NIOSH certification only applies to a respirator as it was originally tested. Even the slightest modification to a certified respirator may affect its fit, form or function, thereby voiding its NIOSH certification. This N95 respirator was tested in its original form and received NIOSH certification.

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NIOSH Approved N95 Particulate Filtering Facepiece Respirators

There are some products that are approved by NIOSH as an N95 respirator and also cleared by the Food and Drug Administration (FDA) as a surgical mask. These products are referred to as Surgical N95 Respirators. View a definition of Surgical N95 Respirators. For your convenience the Surgical N95 Respirators are indicated with the Model Number

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NIOSH, FDA announce streamlined approval process for

May 31, 2018 Washington Manufacturers of certain N95 respirators will be able to submit a single application to NIOSH, rather than to both the Food and Drug Administration and NIOSH, before marketing their product to the health care industry, according to an FDA final order published in the May 17 Federal Register. Previously, all N95 filtering facepiece respirators designed for use in health care

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Guidance for Industry and FDA StaffSurgical Masks

Guidance for Industry and FDA Staff Surgical Masks Premarket Notification [510(k)] Submissions This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.

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How Can You Be Sure Your Respirator is Truly NIOSH

Mar 31, 2016 Buyer Beware (Content sourceNIOSH) NIOSH has become aware of a counterfeit N95 Respirator on the market. While the TC number and private label holder (KOSTO) are valid, this unapproved unit can be identified by the misspelling of NIOSH on the front of the respirator.

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