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A Surgeon's Gloves is worn on the hand of operating room personnel to protect surgical wound from contamination and prevent contaimination between operating room personnel and patient.

Powder Free SterikSurgeon's Gloves

The provided text is a letter from the FDA regarding a 510(k) notification for "Shang Ho Powder Free Latex Surgical Gloves." This document is a regulatory approval and does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria in the way typically associated with AI/ML medical devices (e.g., performance metrics, ground truth, sample sizes, expert qualifications, etc.).

The letter confirms substantial equivalence to a predicate device based on the indications for use. It primarily discusses regulatory compliance, manufacturing practices, and labeling.

Therefore, I cannot extract the requested information about acceptance criteria and study details from the provided text. The questions you've asked are relevant for AI/ML device submissions, but this document pertains to a traditional medical device (surgical gloves).

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