(88 days)
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination between patient and examiner.
Extra-Care Powder Free Latex Patient Examination Glove - Polymer Coated
I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a patient examination glove, confirming its substantial equivalence to a predicate device. It does not contain details about specific performance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for the 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.