(140 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.
PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDERED
The provided text is a 510(k) premarket notification letter from the FDA regarding a Patient Examination Glove. This document primarily addresses the substantial equivalence of the device to legally marketed predicate devices and outlines general regulatory compliance.
It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or any analytical or clinical performance data typically associated with a "device" in the context of AI tools or diagnostics.
Therefore, I cannot extract the requested information as it is not present in the provided document. The sections you asked for, such as sample size, ground truth establishment, expert qualifications, and AI-related performance metrics, are entirely absent.
§ 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.