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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves with peppermint flavor

This is a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves with Peppermint Flavor." The document you provided does not contain any information about a study that proves the device meets acceptance criteria.

The context of this document is a regulatory approval, where the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is generally based on demonstrating that the new device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, that the new device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

For devices like examination gloves, the "acceptance criteria" and "study" to prove substantial equivalence typically relate to meeting relevant ASTM (American Society for Testing and Materials) standards or similar international standards for physical properties (e.g., tensile strength, elongation, barrier integrity like freedom from holes). The document you provided is the FDA's clearance letter and the "Indication for Use" statement, not the detailed testing report.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

• No acceptance criteria or device performance table: The document does not specify quantitative acceptance criteria (e.g., maximum allowable defect rate, minimum tensile strength) nor does it report the device's performance against such criteria.
• No information on study details: There is no mention of sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for any performance testing. This notification focuses on regulatory clearance, not detailed performance study results.

To fulfill your request for this type of device, a different set of documents would be needed, specifically the test reports included in the 510(k) submission that describe adherence to relevant performance standards for examination gloves.

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