(28 days)
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.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).