(30 days)
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.
Pre-powdered Nitrile Patient Examination Glove. BLUE AND WHITE (NON-GLORED)
The provided document is a 510(k) premarket notification letter from the FDA for a Powdered Nitrile Examination Glove. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.
The letter explicitly states it's a review of the company's "Section 510(k) notification of intent to market the device" and determines the device is "substantially equivalent" to legally marketed predicate devices. This indicates a traditional medical device (like gloves), not an AI/ML device that would require performance studies against specific acceptance criteria.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.
§ 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.