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"An examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner." In addition, the glove is suitable for oncology use.

Powder-Free Natural Rubber Latex Examination Glove (Tested For Use With Chemotherapy Drugs) With Protein Content Labeling Claim (50 micrograms or less)

This document is a marketing approval letter for a medical device (a glove), not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, and performance metrics cannot be extracted.

The document states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates that the device meets the regulatory requirements for marketing, but it does not provide specific performance criteria or the results of a scientific study as you would expect for evaluating an AI medical device.

Specifically, none of the requested information (points 1-9) can be found in the provided text. The document pertains to regulatory approval based on substantial equivalence, not a clinical or technical performance study.

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