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This glove is disposable and intended for medical purpose that is hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves with Peppermint Flavor

This document is an FDA 510(k) clearance letter for "Powder Free Nitrile Examination Gloves with Peppermint Flavor." It explicitly states that the device is "intended for medical purpose that is hand to prevent contamination between patient and examiner."

The provided text does not contain any information about acceptance criteria, device performance metrics, study design, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as typically found in a clinical or performance study report for an AI/ML device.

Therefore, I cannot answer your specific questions in the table format requested, nor can I elaborate on the various study design elements because this document does not describe such studies. This is a regulatory clearance letter based on substantial equivalence, not a detailed technical or clinical performance study report.

The clearance is based on the device being "substantially equivalent" to legally marketed predicate devices, implying that its safety and effectiveness for its stated indication are comparable to existing products, without necessarily requiring new clinical performance studies for this type of device (examination gloves).

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