(30 days)
A 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 Nitrile Patient Examination Glove BLUE AND WHITE
This document is a 510(k) clearance letter from the FDA for a Powder-Free Nitrile Examination Glove. It is not a study or a technical report that would contain the detailed information requested about acceptance criteria and device performance studies.
Therefore, I cannot provide the requested information from the provided text. The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, but it does not detail the specific performance studies, acceptance criteria, or ground truth establishment that would be part of such a submission.
§ 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.