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An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner.

Non-Sterile, Powderfree Nitrile Patient Examination Glove

I am sorry, but the provided text from the FDA letter does not contain information about the acceptance criteria or a study that proves a device meets such criteria. The letter is a 510(k) clearance for "Skinsense Nitrile Powder-Free Synthetic Medical Examination Gloves," indicating that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

The document discusses:

• The device being cleared for marketing.
• Regulatory classifications and general controls provisions.
• Contact information for various FDA offices.
• The intended use of the examination gloves: "An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner."

There is no mention of specific performance metrics, acceptance criteria, study design, sample sizes, expert qualifications, or comparative effectiveness studies in this document.

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