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A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves are available with finger textured surface. Sizes; Extra Small and XX-Large.

Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XS, Model SNAEFT-240OR-XS Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XXL, Model SNAEFT-240OR-XXL

This is a 510(k) premarket notification for "Midas Touch-Nitrile Examination Gloves". This document does not describe a study involving device performance metrics, algorithms, human readers, or ground truth as would be found in a submission for an AI/ML-based medical device. Instead, it is an administrative letter from the FDA confirming substantial equivalence for a physical medical device (examination gloves) to predicate devices.

Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text. The prompt's questions pertain to acceptance criteria and studies for AI/ML device performance, which are not relevant to this document.

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