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Powder Free Vinyl Patient Examination Gloves, Colored (White) 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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (White)".

This product is a medical device (patient examination gloves), which falls under a different regulatory and testing paradigm than AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test/training sets, adjudication methods, MRMC studies, and ground truth for AI) are not applicable.

However, I will provide the information based on the provided text, indicating "Not Applicable" where appropriate for an AI/SaMD context.

Acceptance Criteria and Study for "Powder Free Vinyl Patient Examination Gloves, Colored (White)"

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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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow):

Acceptance Criteria and Device Performance Study

The information provided describes the non-clinical testing performed to establish substantial equivalence for the Powder Free Vinyl Patient Examination Gloves, Colored (Yellow).

1. Table of Acceptance Criteria and 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 regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)":

This document is a 510(k) Premarket Notification Summary for a Class I medical device, specifically patient examination gloves. As such, the "study" described is a demonstration of substantial equivalence to a predicate device, primarily through meeting established performance standards rather than a typical clinical trial.

Acceptance Criteria and Reported Device Performance

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