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

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, Trade Name: Powdered

The provided text is a 510(k) clearance letter from the FDA for "Disposable Vinyl Synthetic Exam Gloves, Trade Name: Powdered". This type of document does not contain acceptance criteria or a study proving device performance in the way you've described for a typical medical device with analytical or clinical performance metrics.

A 510(k) clearance signifies that a device is "substantially equivalent" to a predicate device already legally marketed. This process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on a detailed performance study with specific acceptance criteria, sample sizes, expert ground truth, or statistical analysis.

However, I can extract the following relevant information from the provided document:

• Device Name: Disposable Vinyl Synthetic Exam Gloves, Trade Name: Powdered
• Regulatory Class: I
• Product Code: LYZ
• Indications For Use: "A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER."
• Applicant: Shanghai Palomar Mountain Industries, Incorporated
• FDA Decision: Substantially equivalent to devices marketed prior to May 28, 1976.
• Type of Submission: Premarket Notification (510(k))
• Decision Date: February 19, 1999

To reiterate, the kind of detailed study information you're asking for (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is typically found in clinical trial reports, detailed performance studies, or regulatory submissions that go beyond a standard 510(k) clearance letter, especially for Class II or Class III devices, or for devices with more complex functionality that require demonstrable analytical and clinical performance. For a Class I device like examination gloves, the clearance process is significantly less rigorous in terms of performance study requirements.

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