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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Vinyl Exam Glove, Powdered

The provided document is a 510(k) clearance letter from the FDA for a Disposable Vinyl Exam Glove, Powdered. This letter indicates that the device has been found substantially equivalent to a predicate device already on the market.

However, the request asks for information related to the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI-powered medical device. The document provided does not contain any information about AI, algorithms, or any studies involving performance metrics like sensitivity, specificity, or reader studies.

The 510(k) pathway for a medical glove typically focuses on aspects like material biocompatibility, physical properties (e.g., tensile strength, elongation), and barrier integrity (e.g., freedom from holes). These would be assessed through standard engineering and materials testing, not through clinical or AI-related performance studies.

Therefore, I cannot provide the requested information based on the given document. The document primarily concerns the regulatory clearance of a standard medical device (gloves) under the 510(k) process, which does not involve AI performance evaluation.

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