(78 days)
A medical glove is a disposable device which is worn on the hand of healthcare personnel to prevent contamination between patient and examiner.
Powdered Synthetic Vinyl Patient Examination Gloves, Yellow
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets these criteria. The document is a 510(k) premarket notification letter from the FDA regarding "Powdered Synthetic Vinyl Patient Examination Gloves, Yellow." It primarily discusses the substantial equivalence determination for this medical glove and regulatory compliance.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study details
- Standalone performance study details
- 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.