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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 5250-0084.

The provided text is related to a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves," not an AI-powered medical device study. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable.

However, I can extract the relevant information about the device's performance based on the provided document:

Acceptance Criteria and 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 5250-004.

Acceptance Criteria and Study for Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves

This document summarizes the acceptance criteria and the study conducted to demonstrate that the Blue Sail (Brand) Powdered Vinyl Patient Examination Gloves meet these criteria, as described in the provided 510(k) summary (K032783).

1. Table of Acceptance Criteria and Reported Device Performance

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