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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 GINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN (YELLOW GOLD)

This document is a 510(k) clearance letter from the FDA for a medical device: "Opus-E Disposable Powder Free Vinyl Synthetic Exam Gloves With Vitamin Complex, Nopal and Lanolin (Yellow Gold)".

The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions. It does not contain information about:

1. Acceptance criteria and reported device performance: This document is a regulatory approval, not a performance study report.
2. Sample size and data provenance: No study data is presented.
3. Number and qualifications of experts for ground truth: No ground truth establishment is discussed for a study.
4. Adjudication method: Not applicable as no study is detailed.
5. MRMC comparative effectiveness study: No such study is mentioned.
6. Standalone performance study: No such study is mentioned.
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document is a clearance letter, indicating regulatory approval based on substantial equivalence, not a detailed report of a performance study with acceptance criteria.

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