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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes the acceptance criteria and performance of "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It does not pertain to an AI/ML device or software. Therefore, many of the requested categories in the prompt are not applicable.

Here's the information that can be extracted relevant to the prompt, acknowledging the nature of the device:

1. A table of acceptance criteria and the reported 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)":

This device, a patient examination glove, is a Class I medical device, which typically requires less rigorous testing than higher-class devices. The primary focus of the testing is to demonstrate substantial equivalence to a predicate device and adherence to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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