(70 days)
A 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.
Powder Free Black Nitrile Examination Gloves
This document is an FDA 510(k) clearance letter for "Powder Free Black Nitrile Examination Gloves." It does not contain any information about an AI/ML device, its acceptance criteria, or a study proving its performance.
Therefore, I cannot provide the requested information about acceptance criteria and a study from this document. The document primarily focuses on regulatory approval for a physical medical device (gloves) based on substantial equivalence to existing products.
§ 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.