(12 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Powder Free Vinyl Examination Gloves
This document is a 510(k) clearance letter from the FDA for Powder Free Vinyl Examination Gloves. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.
It does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically found in a clinical study report or performance evaluation section.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory compliance rather than detailed technical or clinical performance data.
§ 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.