(46 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Pink
This document is a 510(k) clearance letter from the FDA for Powder Free Nitrile Examination Gloves. It primarily addresses regulatory approval and does not contain the detailed technical study information required to answer your specific questions about acceptance criteria and device performance evaluation as typically found in a clinical or performance study report for diagnostic or AI-enabled devices.
Therefore, I cannot provide the information requested in your prompt based on the provided text. The document focuses on the administrative process of market clearance for a class I medical device (gloves), which has a much lower regulatory bar and different submission requirements compared to a device that would require the kind of performance study details you are asking for.
§ 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.