(121 days)
a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
This device is not intended to be used as a chemical barrier.
Textured Powder-Free Nitrile Examination Glove, Blue Color Tested for Use with Chemotherapy Drug
This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, which is a Textured Powder-Free Nitrile Examination Glove. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.
The letter simply states that the FDA has reviewed the 510(k) submission and determined the device (the examination glove) is substantially equivalent to legally marketed predicate devices. This means it can proceed to market subject to general controls.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory approval process for a physical medical product, not on the performance evaluation of an AI-powered medical device through studies with specific acceptance criteria.
§ 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.