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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 5250-00c4

Here's a breakdown of the acceptance criteria and study information for the device based on the provided text:

1. Table of Acceptance Criteria and 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 5250-0084.

This document is a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)". It is for a medical device (gloves), not an AI/ML-driven diagnostic or prognostic device. Therefore, many of the requested categories in the prompt regarding AI/ML studies are not applicable.

Here's the information that can be extracted from the provided text, adapted to the nature of the device:

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

Ask a specific question about this device