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

The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex. The glove is coated with hydrogel polymer coating. The glove is 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.

The provided document describes a 510(k) premarket notification for "Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating." This is a medical device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or a new clinical benefit through extensive clinical studies. Therefore, many of the typical elements of AI/software device studies (like MRMC studies, training set details, or complex ground truth establishment) are not applicable here.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with ASTM standards and regulatory requirements for surgical gloves. The "reported device performance" refers to the results of tests conducted to demonstrate this compliance.

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