(126 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
VitalCare Exam Gloves (Latex), Paude
I am sorry, but based on the provided document, I cannot answer the question regarding acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for VitalCare Latex Exam Gloves, Powdered, and it primarily focuses on the regulatory clearance process and the device's substantial equivalence to legally marketed predicate devices.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The document confirms the device's classification and allows its marketing, but it does not provide the detailed study results or acceptance criteria you are asking for.
§ 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.