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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.

Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavor.

The provided document describes a 510(k) premarket notification for "Green Powder Free Nitrile Medical Examination Gloves with Peppermint Flavor." It's a regulatory letter from the FDA affirming substantial equivalence to a predicate device.

Crucially, this document is a regulatory approval letter and does not contain the technical details of a study demonstrating the device meets specific acceptance criteria, nor does it report performance metrics from such a study.

Therefore, I cannot provide the requested information. The document focuses on the regulatory classification and approval process, not the results of a scientific study evaluating the device's performance against detailed acceptance criteria.

To elaborate on why the requested information cannot be extracted from this document:

• Acceptance Criteria & Device Performance: The document does not list any quantitative or qualitative acceptance criteria for the gloves' performance (e.g., tensile strength, barrier integrity, tear resistance, flavor potency). It also does not report any test results for these or other parameters.
• Study Details (Sample Size, Ground Truth, Experts, Adjudication): There is no mention of any study design, sample sizes for test or training sets, data provenance, number or qualifications of experts, or methods for establishing ground truth or adjudication.
• MRMC or Standalone Studies: No information is provided about multi-reader multi-case studies or standalone algorithm performance, as these concepts are not applicable to a physical medical examination glove.
• Training Set: The concept of a "training set" is relevant to machine learning models, not to physical medical devices like gloves.

In summary, the provided text is a regulatory communication, not a scientific study report.

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A surgeon's-glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. (21CFR 878.4460)

Sterile Powder Free Latex Surgeon Gloves with Protein Content Labeling Claim (50 micrograms or less)

This document is a 510(k) clearance letter from the FDA for "Sterile Powder Free Latex Surgeon's Gloves with Protein Labeling Claim (50 Micrograms or Less Per Gram of Glove)". It does not contain information about acceptance criteria and device performance in the context of a study for an AI/ML powered device.

The information provided describes the regulatory classification of the gloves, the predicate device, and general regulatory requirements for marketing the device. It also includes the indicated use of the gloves.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics from this document.

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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.

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Ask a specific question about this device

Ask a specific question about this device