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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document, K182575, is a 510(k) Premarket Notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". As such, it does not contain the type of acceptance criteria and study data typically associated with a "device" in the context of an AI/ML medical device, which would involve performance metrics like accuracy, sensitivity, specificity, and a detailed human-in-the-loop (HITL) study.

This submission is for a Class I medical device (patient examination glove), which, by regulation, has a much lower bar for demonstrating substantial equivalence to a predicate device. The "performance data" here refers to physical and biological characteristics of the glove, not diagnostic or predictive performance.

Therefore, I cannot provide the requested information in the format of AI/ML device studies because the provided document does not pertain to such a device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to manufacturing and material standards, not clinical diagnostic accuracy.

However, I can extract the information relevant to this specific device type and its "studies":

Acceptance Criteria and Device Performance (for a physical medical device: Examination Glove)

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