(101 days)
Nitrile Powder-free Examination Glove, ProBlue is a disposable device made of synthetic materials intended for medical purposes that are worn on the examiner's hand or finger(s) to prevent contamination of potentially infectious materials between patient and examiner.
Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735
The provided text is a 510(k) premarket notification letter from the FDA regarding "Nitrile Powder-Free Examination Gloves, ProBlue, #7235 & #7735." This document outlines the FDA's determination of substantial equivalence for a medical device and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria for an AI/ML product.
The letter is for a physical medical glove and discusses regulatory compliance for manufacturing and marketing, not the performance metrics of a software or AI device. Therefore, I cannot generate the requested table and study information based on this document.
§ 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.