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ISO 13485 N95 Face Mask

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Guest user Created:   Mar 31, 2020 Last commented:   Apr 03, 2020

ISO 13485 N95 Face Mask

ISO13485 N95 Face Mask - is this considered a class two device? ISO 13485 tested and approved N95 Face Mask - would this be considered an FDA approved class two device?
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Kristina Zvonar Brkić Apr 03, 2020

Yes, N95FaceMasks are considered as class II devices regulated by the FDA. These masks are used and worn by health care personnel during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material.

Implemented ISO 13485 and approved N95 Face Mask is enough to be considered as FDA approved class II devices.  Generally, class II devices must receive premarket clearance from the FDA under section 510(k) Clearances. However, N95s are exempt from this 510(k) Clearance requirements according to the  Memorandum of Understanding MOU 225-18-006. 

For more details about this decision, please read an article on the following link: https://www.fda.gov/about-fda/domestic-mous/mou-225-18-006

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Mar 31, 2020

Apr 03, 2020