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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.

Powdered Latex Patient Examination Gloves

The provided document is a 510(k) premarket notification for a Powdered Latex Examination Glove. This product is a medical device, but it is not an AI/ML-driven diagnostic or treatment device. The 510(k) clearance process for such a device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria in the manner of AI/ML algorithms.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document.

The document essentially states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness profile as a device already on the market. The "acceptance criteria" here would be meeting the requirements for substantial equivalence as defined by the FDA.

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