(299 days)
A Powder-free pateint examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Black Nitrile Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for Powder Free Black Nitrile Examination Gloves. It primarily discusses the regulatory classification and general controls for the device and confirms its substantial equivalence to a predicate device.
It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or information about AI/ML models.
Therefore, I cannot provide the requested information based on the input 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.