- PPE is commonly used in health care settings such as hospitals, doctor’s offices and clinical labs
- When used properly, PPE acts as a barrier between infectious materials such as viral and bacterial contaminants and your skin, mouth, nose, or eyes (mucous membranes)
- The FDA regulates surgical masks and surgical N95 respirators differently based on their intended use.
You may search the FDA Product Classification Database to determine if there is an existing product classification that applies to your product:
Most Class II (moderate risk) devices require a Premarket Notification 510(k) clearance from the FDA before they may be legally marketed.
A Premarket Notification 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate.
See below for current User Fee.
N95 respirators intended for use in a health care setting during procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate material, are regulated under product code MSH, class II medical devices exempt from 510(k) Premarket Notification.
There are several exceptions.
- intended to prevent specific diseases or infections
- labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity
- contains coating technologies unrelated to filtration (reduce and or kill microorganisms).
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