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A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves

The provided document is an FDA 510(k) clearance letter for Powder Free Nitrile Synthetic Rubber Examination Gloves. It does not contain any information about acceptance criteria or a study related to a medical device's performance for diagnosis or treatment.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document pertains to the clearance of examination gloves, which are Class I devices and generally rely on established performance standards (e.g., ASTM standards for barrier integrity, dimensions, etc.) rather than clinical efficacy studies with expert ground truth establishment for software or diagnostic devices.

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