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Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non Sterile Powder Free Latex Examination Gloves

The provided document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Latex Examination Gloves." It certifies that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI/software performance as requested in your prompt.

The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices (e.g., for diagnostic imaging), where performance metrics like sensitivity, specificity, or AUC are critical, and detailed study methodologies are required to demonstrate clinical validity.

This document pertains to a Class I medical device (non-powdered patient examination glove) which is a physical product, not a software or AI-based device. Therefore, the type of information you are seeking (AI performance, MRMC studies, ground truth establishment for algorithms, etc.) is not applicable and not present in this document.

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