APR 1 4 K11 2025

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The document is a 510(k) summary submitted by Shijiazhuang Glory Plastic Co., Ltd. for their Non-Sterile Powder Free Vinyl Examination Gloves, Clear (Non-colored). It outlines the device's safety and effectiveness in accordance with FDA regulations, identifies its classification and predicate device, describes its intended use as a disposable medical glove to prevent contamination, and confirms that it meets relevant ASTM standards. The summary concludes that the gloves are substantially equivalent to legally marketed devices.

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