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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

A 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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-free Vinyl Patient Examination Glove, 80LYZ , powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

The provided text is related to the 510(k) submission for SHANGHAI GLOVMAX ENTERPRISE CO., LTD. Powder-free Vinyl Examination Gloves. This information primarily focuses on the device's substantial equivalence to a predicate device and its compliance with established standards for medical gloves. It does not include details about a study evaluating an AI/ML powered medical device, or any study that would typically report metrics like sensitivity, specificity, or reader performance.

Therefore, I cannot extract the requested information using the provided text. The document describes a traditional medical device (gloves) and its regulatory clearance process, not a software or AI-based device study.

If you have a document describing a study for an AI-powered medical device, please provide that text, and I will be happy to attempt to answer your questions.

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