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Latex Powdered Examination Glove with Protein Labeling Claim of 200 Microgram or Less Per Gram of 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 examiner.

Latex Powdered Examination Gloves with Protein Labeling Claim of 200 Microgram or Less Per Gram of Glove

I am sorry, but the provided text describes the FDA 510(k) premarket notification for Latex Powdered Examination Gloves. It does not contain any information about a medical device that utilizes AI or machine learning, nor does it discuss acceptance criteria, study methodologies, or performance metrics for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves a device meets the acceptance criteria based on this document. The information you are asking for (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies) is completely absent from this FDA approval letter for gloves.

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A patient examination Latex Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Powdered Examination Glove

The provided text is a 510(k) premarket notification letter from the FDA to High Momentum SDN. BHD. regarding a Latex Powdered Examination Glove. It primarily addresses the substantial equivalence determination for the device, and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a predicate device, not on detailed performance study results against specific criteria.

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