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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Patient Latex Examination Glove (Prepowdered)

This document is a 510(k) premarket notification letter from the FDA regarding a patient latex examination glove. It does not contain any information about acceptance criteria, study methodologies, device performance data, or ground truth establishment. Therefore, I cannot fulfill your request based on the provided text.

The letter merely states that the device is substantially equivalent to a legally marketed predicate device and permits its marketing. It does not include any performance data or study details.

To answer your request, I would need a document presenting the results of a device performance study, including the aspects you listed (acceptance criteria, reported performance, sample sizes, ground truth methodology, etc.).

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