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A patient examination glove is a disposable device intended for medical purposes that is wom on the examiner's hard and finger to prevent Contamination between patient and examiner.

Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim

I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for "Powdered Latex Examination Gloves With Trade Name: Protein Content Labeling Claim," dated June 24, 1997.

This letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to the market. It discusses regulatory classifications, general controls, and responsibilities under the Federal Food, Drug, and Cosmetic Act.

There is no mention of:

• Specific acceptance criteria for device performance.
• Details of any study conducted to prove the device meets performance criteria (such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types/establishment).
• Reported device performance metrics.

Therefore, I cannot generate the table or provide the requested study details based on the given text.

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