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THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURP THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove

The provided text is a 510(k) premarket notification letter from the FDA regarding "Pre-Powdered Latex Examination Gloves White Color with Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove."

This document is a regulatory approval letter, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, which means it has met the regulatory requirements for safety and effectiveness based on comparison to existing devices, rather than through performance in a clinical study with specific acceptance criteria as you've outlined.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert ground truth, or adjudication methods for a new performance study. The FDA's decision is based on a review of the company's submission, which likely included test methods and results demonstrating the gloves met the protein labeling claim and other general device requirements, but this is not presented as a standalone study report with acceptance criteria in this letter.

Here's why I cannot complete the table or answer the specific questions based on the provided text:

• Acceptance Criteria and Reported Device Performance: This document does not detail specific performance acceptance criteria for a new study. The primary "performance" mentioned is the "Protein Labeling Claim 100 Micrograms Water Soluble Protein or Less Per Gram of Glove," which is a characteristic of the glove rather than a clinical performance metric. The letter indicates the device is "substantially equivalent" to a predicate device, meaning it meets the same safety and efficacy profiles as an already approved device.
• Sample sizes, data provenance, ground truth, adjudication, MRMC study, standalone performance, training set details: These are all aspects of a clinical or performance study report, which is not what this FDA letter is. The letter confirms a regulatory decision, not the details of an independent performance study.

In summary, the provided document is a regulatory approval letter based on substantial equivalence, not a detailed scientific study protocol or results report.

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