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For a surgical mask that is also an N95 Respirator and certified by NIOSH as a respirator, you may submit the NIOSH certification number in lieu of filter efficiency performance and differential

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Surgical Mask and Gown Conservation Strategies fda.gov

The FDA recognizes that the need for personal protective equipment PPE , such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to healthcare

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Surgical Gowns. A surgical gown is regulated by the FDA as a Class II medical device that requires a 510 k premarket notification. A surgical gown is a personal protective garment intended to be

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CDC NIOSH Approved N95 Particulate Filtering Facepiece

Jan 23, 2018 & 0183;& 32;You can select a particular manufacturer by clicking on the first letter of their name on the index below. 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.

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manufacturer surgical mask for FDA certification