(62 days)
A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.
Powder - Free Nitrile White and Blue Examination Gloves
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for "Powder-Free Nitrile White and Blue Examination Glove" and an "Indication for Use" statement from the manufacturer.
This document describes the regulatory clearance of a medical device (examination gloves) based on substantial equivalence to a legally marketed predicate device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML powered device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary 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.