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A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Nitrile Patient Examination Gloves, Trade Name: Powdered, Non-Sterile

This document is a 510(k) clearance letter from the FDA for Nitrile Patient Examination Gloves. It focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed performance studies with acceptance criteria for a new AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/diagnostic device is not contained in the provided text.

The document does include:

• Device Name: Nitrile Patient Examination Gloves, Trade Name: Powdered, Non-Sterile (later specified as RS Nitrilstat Medical Examination Gloves, Powdered (Non-Sterile)).
• Applicant: Riverstone Resources Sdn. Bhd.
• Intended Use: "A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient."

Without a document detailing the performance study for such a device, I cannot fulfill the request.

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