(296 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
POWDER-FREE VINYL EXAM GLOVES
This document is a 510(k) premarket notification decision letter from the FDA for "POWDER-FREE VINYL EXAM GLOVES." It is not a study report or technical documentation that describes acceptance criteria for an AI/ML medical device. Therefore, I cannot extract the requested information.
The document confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not contain any details about performance testing, sample sizes, expert review, or ground truth establishment relevant to AI/ML device evaluation.
§ 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.