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A medical glove is worn on the hand of the health care and similar personnel to Prevent contamination between the personnel and the patient being treated.

NBR 4 Mils, Nitrile Examination Glove Non-Sterile, powdered

This is a letter from the FDA regarding a 510(k) submission for a medical device (nitrile examination glove). It primarily discusses the device's substantial equivalence to a predicate device and its regulatory classification, allowing it to be marketed. The document does not contain information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations. It's a regulatory approval letter, not a clinical study report.

Therefore, I cannot provide the requested information based on the provided text.

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A medical glove is worn on the hand of the health care and similar personnel to Prevent contamination between the personnel and the patient being treated.

NBR 4 Mils Nitrile Powder Free Examination Gloves Non-Sterile

This document is a 510(k) premarket notification from the FDA for NBR 4 Mils Nitrile Powder-Free Examination Gloves. It details the FDA's decision regarding the substantial equivalence of the device.

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter acknowledges the submission and clarifies regulatory aspects but does not include technical performance data, test results, or study details.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, rather than detailed performance and study data.

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