(39 days)
A 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.
VINYL EXAM GLOVES, POWDER-FREE, YELLOW
The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria.
The document is a US FDA 510(k) clearance letter for "Vinyl Exam Gloves, Powder Free, Yellow." It states that the device is substantially equivalent to legally marketed predicate devices. This type of clearance relies on demonstrating substantial equivalence to pre-existing devices, rather than presenting new performance study data against specific acceptance criteria.
Therefore, I cannot provide the requested information based on 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.