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A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

HWA and Silktex Powdered Latex Examination Gloves

This document is a 510(k) clearance letter from the FDA for examination gloves. It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices or AI algorithms. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance.

Therefore, I cannot provide the requested information. The document does not describe the specific acceptance criteria or a study with performance metrics, sample sizes, expert qualifications, or ground truth details. The FDA's determination of substantial equivalence for these types of devices is usually based on adherence to recognized standards and successful prior registrations, rather than a detailed performance study as would be required for novel or high-risk devices/algorithms.

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