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Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Powder-free Vinyl Patient Examination Gloves, Colored (Yellow).

It's important to note that this document is for a Class I medical device (patient examination gloves). For devices of this classification, the regulatory requirements are generally less stringent compared to higher-risk devices, and often the "studies" primarily involve adherence to recognized standards rather than complex clinical trials or AI performance evaluations.

Here is the requested information:

1. Table of acceptance criteria and the reported device performance

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