(19 days)
A patient examination gloves 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.
Powdered Vinyl Patient Examination Gloves
The provided documents are FDA correspondence regarding a 510(k) premarket notification for "Disposable Powdered Vinyl Patient Examination Gloves." This type of document is a regulatory approval and does not contain the detailed performance study information requested about acceptance criteria, sample sizes, ground truth establishment, or AI-related metrics. It primarily focuses on demonstrating substantial equivalence to a predicate device based on general safety and effectiveness.
Therefore, I cannot extract the requested information from the provided text. The document states that the device is "substantially equivalent ... to legally marketed predicate devices," implying that its performance is considered acceptable by meeting the standards established for those predicate devices. However, the specific study details are not present.
§ 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.