(90 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 document is a 510(k) clearance letter from the FDA for "Powdered Vinyl Patient Examination Gloves". This document pertains to the regulatory clearance of a physical medical device (gloves), not an AI/ML powered device. As such, the information requested about acceptance criteria and studies for an AI/ML device is not present in this document.
Therefore, I cannot provide the requested table and study details.
§ 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.