(69 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves, Coated With Cucumber With Glycerine, Blue Color
This is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. The information provided in the letter and the associated "Indication for Use" statement does not contain the details required to answer the prompt.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number of experts for ground truth, or adjudication methods in a study.
- Information about multi-reader, multi-case comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used, training set sample size, or how ground truth for the training set was established.
This document is a regulatory approval based on "substantial equivalence" to a predicate device, not a detailed technical report of a device performance study with specific acceptance criteria and study results. Therefore, I cannot provide the requested information from 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.