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The Disposable Nitrile Medical Powder-free Glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document is a 510(k) Premarket Notification for a Disposable Nitrile Medical Powder-free Glove. It does not describe an AI/ML-driven medical device. Therefore, the request to describe acceptance criteria and a study proving an AI/ML device meets those criteria cannot be fully answered from this document.

However, I can extract information related to the non-clinical performance testing conducted for this medical device (the glove), which serves a similar purpose to acceptance criteria and study results for verifying performance against established benchmarks.

Here's an adaptation of the requested format focusing on the non-clinical performance of the medical glove, as an AI/ML study was not conducted:

Device: Disposable Nitrile Medical Powder-free Glove (non-AI/ML device)

This document does not pertain to an AI/ML medical device. Therefore, information regarding "Multi-Reader Multi-Case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "effect size of human readers improving with AI," "sample size for training set," and "how ground truth for training set was established" is not applicable.

The following tables and information describe the acceptance criteria and the non-clinical testing proving the device meets these criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

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