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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES & Nopal + Vitamin C

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Opus-E Disposable powder Free Vinyl synthetic Exam Gloves with Nopal & Vitamin E". This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, or clinical trial details.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory declaration, not a detailed performance study summary.

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