(148 days)
A patient examination gloves 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 Exam Glove, Clear/ Yellow
The provided text is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Vinyl Exam Glove, Clear/Yellow." This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software validation.
Instead, this document is a regulatory approval for a physical medical glove. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a device already on the market, or that any differences do not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document because it pertains to a different type of device and regulatory review process.
§ 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.