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

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I am sorry, but this document does not contain the information you are looking for. This is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves, dated August 23, 1999. It does not describe an AI medical device, acceptance criteria or a study proving its performance.

The document discusses:

• The substantial equivalence determination for examination gloves.
• Regulatory classifications and general controls for medical devices.
• Contact information for further inquiries regarding labeling regulations and other responsibilities under the Act.

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