(61 days)
Powdered Vinyl Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Powdered Vinyl Examination Gloves
The provided text describes a 510(k) premarket notification for "Powdered Vinyl Examination Gloves." This document is a regulatory approval letter from the FDA. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/software devices.
The FDA 510(k) clearance process demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study in the way AI devices are evaluated.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from this document. This document pertains to a medical device (examination gloves), not an AI or software device that would typically undergo the types of studies inquiring about.
§ 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.