(46 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.
Chlorinated, Polymer-Coated, Powder-free, Latex Patient Examination Glove
This document is a 510(k) clearance letter from the FDA for a Chlorinated, Polymer-Coated, Powder-Free Latex Examination Glove. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to the prompt's request for AI/device performance studies.
Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data or study methodologies.
§ 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.