(80 days)
A vinyl 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.
POWDER-FREE ELASTIC VINYL EXAMINATION GLOVES
The provided text is a 510(k) premarket notification approval letter for "Powder-Free Elastic Vinyl Examination Gloves". This document is a regulatory approval for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The information requested in the prompt (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in clinical validation studies for AI/ML medical devices. This document only confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.
Therefore, I cannot extract the requested information from 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.