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A powder-free patient examination glove is a disposable device that is worn on the examiners hand or finger to prevent contamination between patient and examiner,

Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA regarding "Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination Gloves." This document is a regulatory approval for a medical device (gloves) and does not contain any information about an AI/ML-driven medical device or any associated study that would include acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods.

Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed are relevant to AI/ML device testing and evaluation, which is not what this document describes.

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