(35 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color." It primarily addresses the substantial equivalence determination for the device. As such, it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be associated with a study demonstrating a device meets acceptance criteria for an AI/CAD system.
The document is for a Class I medical device (patient examination gloves), which typically has much simpler regulatory requirements than more complex devices and certainly does not involve AI or sophisticated image analysis.
Therefore, I cannot provide the requested information from the given text. The provided text does not describe a study that proves a device meets acceptance criteria in the way you've outlined for an AI/CAD system.
§ 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.