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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.

Jiatai Synthetic Vinyl Exam Gloves, Powdered, USP

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shanghai Jiatai Plastic Products Company, Limited regarding their Pre-Powdered Non-Sterile Vinyl Examination Gloves.

This document confirms that the device has been found substantially equivalent to a predicate device and allows it to be marketed. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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A patient examination glove is a disposable device intended for medical purpooses that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Jiatai Synthetic Vinyl Exam Gloves, Powder-Free

The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification letter from the FDA regarding a submission for "Powder-Free Non-sterile Vinyl Examination Gloves." This letter primarily addresses the substantial equivalence determination of the device and regulatory guidelines, rather than detailed performance study results.

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