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Latex examination powderfree gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

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This document is a 510(k) premarket notification letter from the FDA regarding "Top Glove Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram." This type of document is a regulatory approval, not a scientific study report. It confirms substantial equivalence to a predicate device but does not contain detailed information about acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and the reported device performance: This document confirms regulatory compliance, not performance data against specific criteria like sensitivity, specificity, or accuracy for a diagnostic device.
• Sample size used for the test set and the data provenance: Not applicable as no specific performance study is detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical glove, not an AI-assisted diagnostic device.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates a comparison to existing, legally marketed predicate devices, rather than a novel performance study against specific acceptance criteria in the manner of an AI/diagnostic device. The "Indications For Use" section simply describes the purpose of exam gloves.

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