(21 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.
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This document is a 510(k) premarket notification approval letter for "Vinyl Examination Gloves, Pre-Powdered." It does not contain information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot provide a detailed response to your request based on the provided text. The document is an FDA approval for marketing the device, stating it is substantially equivalent to legally marketed predicate devices, but it does not include the technical performance data or study details you are asking for.
§ 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.