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A patient examination glove 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.

On-line Powder-free Nitrile Patient Examination Glove, Violet Color

I apologize, but this document is a 510(k) summary notification from the FDA regarding a medical device, specifically "On-line Powder-free Nitrile Patient Examination Gloves, Violet Color."

This document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.

Instead, it is a letter of substantial equivalence, stating that the FDA has determined the referenced device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It goes on to list general controls and regulatory requirements.

Therefore, I cannot provide answers to the questions you've asked about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the provided text. This information would typically be found in a separate performance study report or design validation documentation, not in this specific FDA clearance letter.

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