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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 finger to prevent contamination between patient and examiner.

Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves

This is a 510(k) clearance letter for disposable examination gloves. This type of device does not typically involve the kind of "acceptance criteria" and "study" that would be performed for AI/ML-powered medical devices as your questions imply. The FDA clearance process for these devices primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to performance metrics against specific criteria for an algorithm.

Therefore, I cannot answer the questions directly as they are not applicable to the provided document. The document describes a traditional medical device (disposable gloves) and its regulatory clearance, not an AI/ML device.

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