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A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

This document is a 510(k) premarket notification letter from the FDA regarding a surgical glove, not a study or report on an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, experts, and sample sizes for an AI device cannot be extracted from the provided text.

The document states that the FDA has determined the ElastyLite® Synthetic Powdered Surgical Glove is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's characteristics and intended use being similar enough to existing devices that it does not require a new premarket approval application (PMA).

To answer your prompt, I would need a different type of document, specifically a clinical study report, a performance evaluation report, or a 510(k) summary for an AI/ML-based medical device.

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