(59 days)
Patient Examination Gloves
A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Vinyl Examination Gloves, Prepowdered, USP
I am sorry, but the provided text does not contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study. The document is a clearance letter from the FDA for a 510(k) submission for "Vinyl Examination Gloves, Prepowdered USP," indicating their substantial equivalence to a legally marketed predicate device. It confirms the device's classification and allows its marketing.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given 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.