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The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Powdered Latex Examination Gloves with Protein Content Labeling Claim of 200 micrograms or less.

This looks like a 510(k) clearance letter for a medical device (Powdered Latex Examination Gloves). This type of document does not typically contain the detailed information about acceptance criteria and clinical study results that you are requesting.

A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, often relying on performance data rather than extensive clinical efficacy studies. The letter confirms the device is cleared for market based on this substantial equivalence.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance: This letter doesn't specify numeric acceptance criteria or detailed performance metrics.
• Sample sized used for the test set and the data provenance: Not present in this document.
• Number of experts used to establish the ground truth... and qualifications: Not present.
• Adjudication method: Not present.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device.
• The type of ground truth used: Not applicable in this context.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The 510(k) "Indications for Use" section (provided as {2} in your input) only states:

• Device Name: Powdered Latex Examination Gloves with Protein Content Labeling Claim of 200 micrograms or less.
• Indications For Use: The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

To find the information you're looking for, you would typically need to review the full 510(k) submission summary or the actual performance data submitted by the manufacturer, which are not included in this FDA clearance letter.

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