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A powdered 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 Nitrile Examination Gloves, Blue

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powdered Nitrile Examination Gloves, Blue". This document does not contain information about acceptance criteria and a study proving the device meets those criteria, as it pertains to a medical glove. The type of information requested (e.g., sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is typically found in submissions for AI/ML-based medical devices or diagnostic tools, not for a physical device like examination gloves.

Therefore, I cannot fulfill your request based on the provided text.

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