(22 days)
A patient examination glove is a disposable device intended for medical purpooses that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Jiatai Synthetic Vinyl Exam Gloves, Powder-Free
The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification letter from the FDA regarding a submission for "Powder-Free Non-sterile Vinyl Examination Gloves." This letter primarily addresses the substantial equivalence determination of the device and regulatory guidelines, rather than detailed performance study results.
§ 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.