(214 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
Powder Free Blue Nitrile Examination Glove
I am sorry, but the provided text from the FDA letter is a 510(k) premarket notification for a Class I medical device (Powder Free Blue Nitrile Examination Glove). This document confirms the device's substantial equivalence to predicate devices and outlines general controls and regulatory requirements.
The document does NOT contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/CAD/imaging device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The questions you've asked are typically relevant for more complex devices, especially those involving AI/machine learning for diagnosis or prognosis, which require rigorous performance evaluation. This document is for a very low-risk physical device.
§ 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.