(56 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, Orange Scented, Orange Powder Free Nitrile Examination Gloves, Vanilla Scented, White
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves." This document announces the substantial equivalence of the device to legally marketed predicate devices.
It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts), MRMC studies, standalone performance, or training set information for an AI/ML device. The letter pertains to a simple medical device (gloves) and not an AI/ML system.
Therefore, I cannot provide the requested information based on the input 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.