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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest

This document is a 510(k) premarket notification acceptance letter from the FDA for Nitrilecare Nitrile Examination Gloves. It primarily deals with the substantial equivalence determination for a medical device and its general regulatory compliance.

Therefore, this document does not contain the information requested regarding:

• Acceptance criteria and reported device performance for an AI/CAD/software device, or any device requiring such a study. The table in the document relates to drug permeation times for gloves, not performance metrics of a diagnostic or therapeutic device.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is a regulatory approval letter for examination gloves. The "study" mentioned is a chemotherapy drug permeation test for the gloves, not a clinical performance study involving AI or human reader improvement.

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