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The provided text is a 510(k) clearance letter from the FDA for "Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors."

This document does not contain any information about an AI/ML medical device, its acceptance criteria, or a study proving its performance. It specifically relates to a Class I medical device (non-powdered patient examination glove) and focuses on regulatory aspects like substantial equivalence, general controls, and compliance.

Therefore, I cannot provide the requested information about acceptance criteria and a study to prove a device meets them, as the provided input does not describe such a device or study.

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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Yellow, Red, Green, Black, Blue with Pearlescent™ Pigment, Powder-Free Nitrile Examination Gloves with Aloe Vera

The provided document is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt. Therefore, I cannot generate the requested table and study description.

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Ask a specific question about this device

Powder-Free Nitrile Exam Glove with Aloe Vera is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Powder-Free Nitrile Exam Gloves with Trade Name: Aloe Vera, Green Color

This document is a 510(k) clearance letter for Powder-Free Nitrile Examination Gloves. It does not contain information on acceptance criteria or a study proving that the device meets those criteria. The letter confirms that the FDA has reviewed the submission and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information.

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