(147 days)
A 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.
POWDER FREE BLUE NITRILE EXAMINATION GLOVE
I am sorry, but based on the provided text, there is no information about a study proving that a device meets acceptance criteria, nor is there any mention of a device that requires such a study.
The document is an FDA 510(k) clearance letter for a "Powder Free Blue Nitrile Examination Glove." This type of device (a Class I medical device) typically does not require extensive clinical studies or AI algorithm performance evaluations to demonstrate substantial equivalence. The clearance is based on comparison to a predicate device and adherence to general controls, good manufacturing practices, and labeling requirements.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance (not applicable for this type of device and clearance).
- Sample size and data provenance for a test set (no such test set or study described).
- Number of experts and their qualifications (not relevant for this clearance).
- Adjudication method (not applicable).
- MRMC comparative effectiveness study (not applicable).
- Standalone algorithm performance (not applicable, as it's a physical glove, not an algorithm).
- Type of ground truth used (not applicable).
- Sample size for the training set (not applicable).
- How ground truth for the training set was established (not applicable).
The document is purely a regulatory letter confirming that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
§ 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.