(58 days)
This glove is disposable and is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Smart Fit ; Nitrile Examination Gloves Prepowdered.
This document is a 510(k) premarket notification approval letter for "Smart-Fit, Prepowdered Nitrile Examination Gloves." As such, it does not contain any information about acceptance criteria or a study proving that a device meets those criteria.
The letter is from the FDA to the manufacturer, acknowledging that the device is substantially equivalent to legally marketed predicate devices. This type of notification focuses on regulatory approval based on equivalence for medical devices, not on the detailed performance studies or statistical metrics typically associated with AI/ML device evaluations.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.