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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using polyisoprene, which is a synthetic rubber latex, and is brown in color. The glove is coated with hydrogel polymer coating.

The gloves are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery

The document describes the acceptance criteria and study for the Cardinal Health™ Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating. This is a medical device, and the study focuses on its physical and biological performance against established standards rather than artificial intelligence or diagnostic capabilities. Therefore, some of the requested information regarding AI-specific elements (like human reader improvement with AI, ground truth for training sets, etc.) is not applicable.

Here's the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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