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A Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent device in between patient and examiner.

Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)

The provided text is a 510(k) premarket notification letter from the FDA regarding "Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)". This document primarily deals with regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.

Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria and performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training). The document is a regulatory approval letter, not a scientific study report.

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A Vinyl examination glove, Powder Free, Clear (Non-Colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Stretch Vinyl Examination Glove, Powder Free (Yellow/White/Clear (non-colored)

The provided text is a letter from the FDA regarding the 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device