(24 days)
The powder-free 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.
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
The provided document is an FDA 510(k) clearance letter for Nitrile Powder Free Examination Gloves. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for software or AI-powered medical devices.
The letter pertains to a Class I medical device (non-powdered patient examination glove), which is a physical product, not a software or AI-driven diagnostic or therapeutic tool. As such, the clearance process for such a device typically involves demonstrating substantial equivalence to a predicate device based on material properties, performance standards (e.g., tensile strength, barrier integrity), and biocompatibility, rather than algorithms, ground truth establishment, or human-in-the-loop studies.
Therefore, I cannot extract the requested information from the provided text because it describes the clearance of examination gloves, not an AI/software medical device.
§ 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.