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A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

A Vinyl examination glove sterile powdered is a disposable device made of polyvinyl chloride paste resin that bears powder to facilitate donning and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

This document is a 510(k) premarket notification letter from the FDA regarding "Vinyl Examination Gloves, Sterile Powdered." It is a regulatory approval, not a study report or clinical trial. Therefore, it does not contain the information requested about acceptance criteria and study details for a device's performance.

To answer your request, a document detailing performance testing, clinical studies, or an substantial equivalence report would be needed. This letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

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