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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 (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and noting areas where the information is not present:

Acceptance Criteria and Device Performance

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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064.

The provided document describes the "Powder Free Vinyl Patient Examination Gloves, white (non-colored)" and its premarket notification (510(k)) summary. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study of device performance against specific acceptance criteria using a test set. This type of submission relies on established standards and non-clinical testing.

Here's an analysis of the available information based on your requested categories:

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

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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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