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A powder-free latex examination gloves is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent cross-contamination between patient and examiner.

Disposable Latex Powder Free Examination Gloves (Non-sterile)

The provided document is a 510(k) clearance letter from the FDA for "Disposable Latex Powder Free Examination Gloves (Non-sterile)". It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document, not a scientific study report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is solely focused on the regulatory clearance process for a medical device (gloves), confirming its substantial equivalence to legally marketed predicates. It does not delve into the detailed performance study data you are seeking.

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