(49 days)
A powder-free patient examination glove is a disposable device that is worn on the examiners hand or finger to prevent contamination between patient and examiner,
Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination Gloves
The provided text is a 510(k) premarket notification letter from the FDA regarding "Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination Gloves." This document is a regulatory approval for a medical device (gloves) and does not contain any information about an AI/ML-driven medical device or any associated study that would include acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed are relevant to AI/ML device testing and evaluation, which is not what this document describes.
§ 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.