(56 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Patient Vinyl Examination Gloves, Yellow, Powder free, Non-Sterile
This document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It primarily addresses regulatory approval and does NOT contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information from the provided 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.