(34 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, Latex Examination Glove coated with Aloe Vera gel and Vitamin E.
This document is exclusively a 510(k) clearance letter from the FDA for a Powder-Free Latex Examination Glove coated with Aloe Vera and Vitamin E.
A 510(k) clearance solely addresses the substantial equivalence of a new device to a predicate device. It does not involve studies to establish acceptance criteria for device performance in the way that would typically be done for AI/ML-driven medical devices.
Therefore, none of the requested information (table of acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance, training set details) is present in this document because it is not relevant to a 510(k) submission for this type of medical device (gloves).
§ 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.