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A patient examination glove made of synthetic rubber is a disposable medical device intended for medical purposes worn on the examoiners hands or fingers to prevent possible contamination between patient and examiner.(Tested for Chemo Use

A patient examination glove made of synthetic rubber is a disposable medical device intended for medical purposes worn on the examoiners hands or fingers to prevent possible contamination between patient and examiner.(Tested for Chemo Use

This document is an FDA 510(k) clearance letter for a medical device: "Modification to Powder-free Colored and Flavored Chloroprene Patient Examination Gloves, Tested for Chemo Use." It is not a study report and therefore does not contain the information requested about acceptance criteria, statistical studies, ground truth establishment, or expert involvement.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared through the 510(k) pathway based on substantial equivalence to a predicate device, rather than through a de novo pathway or by providing a full clinical trial demonstrating safety and effectiveness against specific acceptance criteria. The "Tested for Chemo Use" implies some testing was done to support that claim, but the details of such testing, its acceptance criteria, and methodology are not provided in this regulatory letter.

Therefore, I cannot provide the requested information from this document.

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