(163 days)
A patient Examination Powder 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.
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This is an FDA 510(k) clearance letter for Patient Exam Nitrile Powdered Gloves. It is not a study of an AI/ML device, and therefore does not contain information about acceptance criteria or a study proving device performance as requested.
The document is a regulatory approval for a medical glove, confirming its substantial equivalence to previously marketed devices. It does not involve any AI components or performance metrics suitable for the detailed questions about AI device studies.
§ 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.