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The Top Quality Skingard Polycoat Powdered Latex Examination Glove with Aloe Vera is intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Latex Examination Glove with Aloe Vera

The provided text describes a 510(k) summary for a medical device, specifically a "Powdered Latex Examination Glove with Aloe Vera." The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material properties and intended use. There is no information regarding AI/ML device performance, human reader studies, or ground truth establishment relevant to AI/ML.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance (for an AI/ML device).
• Sample size used for the test set and data provenance (for an AI/ML device).
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
• If a standalone (algorithm only without human-in-the-loop performance) study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• The sample size for the training set (for an AI/ML device).
• How the ground truth for the training set was established (for an AI/ML device).

The document is a 510(k) submission for a physical medical product (gloves), not an AI/ML powered device, and thus does not contain the type of information requested regarding AI/ML device performance and validation studies.

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