(69 days)
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Vinyl Examination Gloves, Powdered
I apologize, but this document is a 510(k) clearance letter from the FDA for "Vinyl Examination Gloves, Powdered." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets them.
The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with detailed acceptance criteria and performance metrics like those described in your prompt for AI/software devices.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.