(36 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.
Polymer Coated Powder Free Nitrile Examination Gloves, BLUE
I am sorry, but the provided text is a government document from the Food and Drug Administration (FDA) and does not contain the specific information you are looking for regarding acceptance criteria, study details, or AI performance metrics. It is a 510(k) clearance letter for a medical device (nitrile examination gloves) and an "Indications for Use Statement." These documents typically focus on regulatory compliance and the intended use of the device, rather than detailed performance studies against specific acceptance criteria.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.