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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein label claim (50 microgram or less)

This document is an FDA 510(k) clearance letter for a medical device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device, "Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein Labeling Claim (50 Micrograms or Less)," is substantially equivalent to legally marketed predicate devices, which allows it to proceed to market.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for establishing ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This type of information is typically found in a clinical study report or a more detailed technical submission, not in the FDA clearance letter itself.

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A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Protein Content labeling Claim (50 micrograms or less)

This document is a 510(k) premarket notification approval letter from the FDA for medical gloves. It does not describe an AI/ML device or its performance criteria, study design, or results. Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document discusses the approval of "Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less)." The letter confirms that this device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

The "Indications For Use" section states: "A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient."

No information regarding AI/ML device performance, acceptance criteria, or study details can be extracted from this document.

Ask a specific question about this device