(39 days)
A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the examiner's hand or finger's for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
A powder-Free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder
The provided text is an FDA 510(k) clearance letter for "Ever-More Powder-Free Latex Examination Gloves" and an "Indication For Use" statement. This document primarily focuses on regulatory approval based on "substantial equivalence" to a legally marketed predicate device.
It does not contain any information about a study that assesses the performance of a device against specific acceptance criteria in the way you've described (e.g., using a test set, ground truth, expert adjudication, or AI performance metrics).
Therefore, I cannot provide the requested information. The document is about a regulatory clearance, not a performance study report.
§ 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.