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A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE. GREEN COLOR.

The provided document is a 510(k) clearance letter from the FDA for "Nitrile Examination Gloves, Powder-Free, Trade Name: Green Color" and includes its "Indication For Use." This document does not contain information regarding detailed acceptance criteria for device performance, specific study designs, sample sizes, expert qualifications, or ground truth establishment for a medical device's algorithm or imaging system.

The letter concerns the substantial equivalence of the gloves to previously marketed devices based on their intended use, and it mentions compliance with general controls provisions such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is strictly an FDA clearance letter for a medical device (nitrile examination gloves), not a study report or a technical performance specification.

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