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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.

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The provided text describes a 510(k) premarket notification for Latex and Nitrile Examination Gloves. It focuses on the substantial equivalence of these gloves to predicate devices and does not contain information about specific acceptance criteria or an analytical study proving that the device meets those criteria.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• 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 primarily covers administrative details, intended use, predicate device information, and the FDA's substantial equivalence determination for examination gloves. Performance data, if any, would typically be found in a separate section detailing testing conducted to standards like ASTM D6319-001 (for nitrile) or ASTM D3578 (for latex), which are common for gloves but not explicitly detailed as "acceptance criteria" or a "study" in this summary.

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