Search Results

Green Non Sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Green Non Sterile Powder Free Nitrile Examination Gloves

The provided text is a 510(k) clearance letter from the FDA for "Green Non Sterile Powder Free Nitrile Examination Gloves." This document is a regulatory communication for a medical device and does not contain information regarding an AI/ML medical device, clinical study results, or performance criteria as would be relevant for devices that use algorithms or sophisticated analytical methods.

Therefore, I cannot extract the requested information (acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) because this information is not present in the provided FDA clearance letter for examination gloves.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls, but it does not detail performance studies or criteria relevant to AI/ML devices.

Ask a specific question about this device