(46 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 betwen patient and examiner.
Powdered patient latex examination gloves
The provided text is a 510(k) premarket notification letter from the FDA regarding "Qualatex Powered Latex Examination Gloves." This document is a regulatory approval for a medical device and does not contain information about the acceptance criteria and study results for an AI/ML powered medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The questions you've asked are specific to the evaluation of AI/ML medical devices, which is not what this document addresses.
§ 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.