(30 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.
Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves
This is a 510(k) clearance letter for disposable examination gloves. This type of device does not typically involve the kind of "acceptance criteria" and "study" that would be performed for AI/ML-powered medical devices as your questions imply. The FDA clearance process for these devices primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to performance metrics against specific criteria for an algorithm.
Therefore, I cannot answer the questions directly as they are not applicable to the provided document. The document describes a traditional medical device (disposable gloves) and its regulatory clearance, not an AI/ML device.
§ 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.