(402 days)
A Powdered Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Vinyl Examination Glove
The provided document is an FDA 510(k) clearance letter for a "Powdered Vinyl Examination Glove." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment related to a specific performance study.
Therefore, I cannot provide the requested information. The letter only states the device's classification, regulation details, and confirms substantial equivalence, which is a regulatory determination, not a performance study report.
§ 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.