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This glove is disposable and intended for surgical purpose that is worn on the surgeon's hand to prevent contamination between patient and surgeon.

Sterile Powder Free Latex Surgical Gloves with protein claim less than 50

The provided text is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria and a study proving a device meets those criteria, as it is a regulatory document rather than a study report. The request asks for details that are not present in this type of document.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study based on the provided input. The document confirms that "Sterile Powder Free Latex Surgical Gloves with Protein Claim Less than 50 Micrograms" from Smart Glove Corporation Sdn Bhd are substantially equivalent to legally marketed predicate devices, but it does not include performance data or study specifics.

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