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powdered 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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.

This document is a 510(k) Premarket Notification summary for medical gloves, not a study of an AI device. As such, it does not contain the information requested in your prompt regarding AI device acceptance criteria and study details.

However, I can extract the relevant information about the device performance and acceptance criteria for the medical gloves as presented in this document.

1. A table of acceptance criteria and the reported device performance:

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