N95 respirators that are both certified by NIOSH and cleared by the FDA as medical devices for use by healthcare personnel are called “surgical N95 respirators.”
NIOSH-certified N95 respirators that have not been cleared by the FDA can be used for respiratory protection to reduce the exposures of healthcare personnel in a patient setting to hazardous particulates. These respirators have not been evaluated by FDA to determine whether they meet the fluid and flammability resistance as required for FDA clearance as medical devices. For this reason, they are not intended for use in exposure settings where the performance of a surgical mask to maintain a sterile field is required.
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