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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color

Unfortunately, the provided text is a letter from the FDA regarding the clearance of "Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color." It does not contain any information about acceptance criteria or a study that proves a device meets those criteria, as typically found in a scientific or performance evaluation report.

The letter is primarily focused on:

• Device Identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
• Regulatory Clearance: Stating that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.
• General Controls: Reminding the applicant of general regulations such as annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: For regulatory advice.
• Indication for Use: A brief description of the intended use of the gloves.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information would be found in a separate performance study report or clinical trial documentation, not in an FDA clearance letter.

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