(327 days)
Single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.
Nitrile Examination Gloves
The provided text is an FDA 510(k) clearance letter for Nitrile Examination Gloves. It does not contain any information about acceptance criteria, device performance, or studies related to AI/algorithm performance.
The letter focuses on regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, product code, and indications for use of the gloves. It also outlines the regulatory obligations of the manufacturer.
Therefore, I cannot provide the requested information based on this document. The questions you've asked are typically relevant to the performance evaluation of a software-as-a-medical-device (SaMD) or AI-powered medical device, 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.