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A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.

POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-free Latex Surgeon's Gloves." It focuses on the regulatory approval process and does NOT contain information about acceptance criteria, study details, or device performance against specific metrics as would be typically found in a clinical or performance study report for AI/medical imaging devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text. The document is a regulatory approval letter, not a scientific study report.

The information you've requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth types, training set details) is not present in this type of FDA correspondence.

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