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A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (as per described in 21 CFR 878,4460)

SENSIFLEX PLUS Sterile Latex Surgical Gloves Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less

I am sorry, but based on the provided document, there is no information about acceptance criteria for a device, a study that proves the device meets specific acceptance criteria, or any of the detailed aspects requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

The document is an FDA 510(k) clearance letter for "SENSIFLEX PLUS Sterile Latex Surgical Gloves Powder Free with Protein Content Labeling Claim with 50ug/dm- or less." It primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include data from a clinical or performance study that would demonstrate the device's accuracy, sensitivity, specificity, or any other performance metrics typically associated with acceptance criteria for a diagnostic or AI-driven device.

The information provided is purely administrative regarding the regulatory clearance of a medical device (surgical gloves).

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