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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:

1. A table of acceptance criteria and reported device performance (not applicable for this type of device and clearance).
2. Sample size and data provenance for a test set (no such test set or study described).
3. Number of experts and their qualifications (not relevant for this clearance).
4. Adjudication method (not applicable).
5. MRMC comparative effectiveness study (not applicable).
6. Standalone algorithm performance (not applicable, as it's a physical glove, not an algorithm).
7. Type of ground truth used (not applicable).
8. Sample size for the training set (not applicable).
9. 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.

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