(83 days)
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.