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A Stretch Vinyl Examination Glove Colored(Yellow/White) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder-Free, Stretch Vinyl Examination Gloves, (Yellow/White)

This document is a 510(k) premarket notification decision letter from the FDA for Powder-Free, Stretch Vinyl Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance document rather than a study report. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information from the provided text. The document does not describe:

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

This type of information is typically found in a separate study report or regulatory submission, not in the FDA's clearance letter itself.

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