(265 days)
A Nitrile powder free 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. (21 CFR 880.6250)
ELEGANT Nitrile Powder Free Examination Gloves
This document is a 510(k) premarket notification decision letter from the FDA for medical examination gloves and does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.
The provided text pertains to the substantial equivalence determination for "Elegant Blue Violet Nitrile Examination Gloves Ambidextrous Powder-Free" (K120110). It states that the device 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." (21 CFR 880.6250).
Therefore, none of the requested information (1-9) can be extracted from this document, as it is not relevant to the performance evaluation of an AI-powered 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.