(95 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
SYNTHETIC VINYL PATIENT EXAM GLOVES PRE-POWDERED, YELLOW
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Patient Examination Gloves Pre-Powdered, Yellow," stating that the device is substantially equivalent to legally marketed predicate devices. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
§ 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.