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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Sterile Latex Examination Gloves (Powdered) with protein claim less than 100 µg/g

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, study details, or performance metrics for a device in the context of medical imaging or AI.

The document is a US FDA 510(k) clearance letter for "Sterile Examination Gloves (Powdered) with Protein Claim 100 Micrograms or Less." It discusses the regulatory classification, general controls, and substantial equivalence to a predicate device.

Therefore, I cannot provide a response to your request, as it pertains to a different type of medical device and study methodology than what is described in the provided text.

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