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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 With Peppermint Scented (Blue Color)

The provided document is a 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves with Peppermint Scented (Blue Color)." This document is a regulatory approval letter for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria.

The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the new device to existing devices that have already been cleared. For devices like examination gloves, the substantial equivalence typically involves demonstrating similar materials, performance characteristics (e.g., barrier integrity, tensile strength), and intended use as the predicate device, rather than a clinical study as would be required for more complex devices.

Therefore, I cannot provide the requested information, as it is not present in the given text.

To answer your specific questions in the context of what would typically be part of a submission for such a device, but which are not detailed in this specific letter:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. For examination gloves, acceptance criteria would typically relate to physical properties like tensile strength, elongation, force at break, viral penetration, and freedom from holes, often adhering to international standards (e.g., ASTM D6319 for Nitrile Examination Gloves).
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and submission. "Ground truth" in this context would typically refer to laboratory test results.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is for diagnostic devices or AI algorithms where human interpretation is involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used: Not explicitly stated, but for examination gloves, "ground truth" refers to laboratory measurements of physical and barrier properties against established standards.
8. The sample size for the training set: Not applicable; this device does not involve machine learning.
9. How the ground truth for the training set was established: Not applicable.

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