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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Coated With Cucumber With Glycerine, Blue Color

This is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. The information provided in the letter and the associated "Indication for Use" statement does not contain the details required to answer the prompt.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts for ground truth, or adjudication methods in a study.
• Information about multi-reader, multi-case comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used, training set sample size, or how ground truth for the training set was established.

This document is a regulatory approval based on "substantial equivalence" to a predicate device, not a detailed technical report of a device performance study with specific acceptance criteria and study results. Therefore, I cannot provide the requested information from the given text.

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