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"This summary of5lO(k) safety and effectiveness information is being submitted in accordance

"This summary of5lO(k) safety and effectiveness information is being submitted in accordance 2025

"This summary of5lO(k) safety and effectiveness information is being submitted in accordance Preview on Page 1

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The document is a premarket notification summary for the Powder Free Vinyl Patient Examination Gloves submitted by Huanfu Plastic Products Limited. It outlines the device's classification, intended use, and substantial equivalence to a predicate device. The gloves are intended for medical purposes to prevent contamination between patient and examiner and meet various safety and effectiveness standards. The FDA has determined that the device is substantially equivalent to legally marketed devices, allowing it to be marketed under general controls.

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