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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR

This document is a 510(k) premarket notification letter from the FDA regarding a Disposable Powder Free Nitrile Exam Glove. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, a "study that proves the device meets the acceptance criteria" is not described.

This document is a regulatory approval letter, not a scientific study report. It states that the device is "substantially equivalent" to existing devices, implying that it meets similar safety and performance standards, but it does not detail specific acceptance criteria or the study data used to demonstrate them.

Therefore, I cannot provide the requested information from the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, or other details about a test set.
3. Information about experts establishing ground truth or adjudication methods.
4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
5. Details of a standalone algorithm performance study.
6. The type of ground truth used.
7. The sample size for the training set.
8. How the ground truth for the training set was established.

The letter simply indicates that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to predicate devices for its stated "Indications For Use": "A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER."

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