(19 days)
A patient examination glove 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.
Vinyl Examination Gloves, Powder Free, Violet Color
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device. The text is a 510(k) premarket notification letter from the FDA to a medical glove manufacturer, confirming the substantial equivalence of their "Vinyl Examination Gloves, Powder Free, Violet Color" to a legally marketed predicate device.
The document discusses regulatory compliance for patient examination gloves but does not contain any scientific study data, performance metrics, or details about how the device's efficacy or safety was evaluated using acceptance criteria.
§ 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.