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The powder-free 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.

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

The provided document is an FDA 510(k) clearance letter for Nitrile Powder Free Examination Gloves. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for software or AI-powered medical devices.

The letter pertains to a Class I medical device (non-powdered patient examination glove), which is a physical product, not a software or AI-driven diagnostic or therapeutic tool. As such, the clearance process for such a device typically involves demonstrating substantial equivalence to a predicate device based on material properties, performance standards (e.g., tensile strength, barrier integrity), and biocompatibility, rather than algorithms, ground truth establishment, or human-in-the-loop studies.

Therefore, I cannot extract the requested information from the provided text because it describes the clearance of examination gloves, not an AI/software medical device.

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