(53 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLOR (BLUE COLOR)
This document is a 510(k) clearance letter for a medical device: "Powder-Free Copolymer Nitrile Medical Examination Glove, Blue Color". As such, it is not a study report or clinical trial document that would typically contain the detailed information requested regarding acceptance criteria and device performance studies for AI/ML devices.
The information provided pertains to the regulatory clearance of a physical medical device (gloves) and focuses on substantial equivalence to a predicate device, not on the performance metrics of a diagnostic algorithm or an AI system.
Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document as it is not relevant to the subject matter.
§ 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.