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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.

Patient Examination Glove, Latex, Powder Free

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Patient Examination Glove, Latex, Powder Free." This document explicitly states that the device is substantially equivalent to legally marketed predicate devices. Crucially, it does not contain the specific information required to complete the table and answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.

The letter is an approval for market entry based on substantial equivalence, not a detailed report of a clinical trial or performance study against specific acceptance criteria. The FDA's finding of substantial equivalence means they believe the device is as safe and effective as a legally marketed predicate device, without necessarily requiring a new, comprehensive performance study that would generate the kind of data requested.

Therefore, I cannot extract the requested information from the provided text. The document is about regulatory approval, not a performance study report.

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