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Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

Latex Surgical Gloves, Powder free with Protein Content Labeling Claim (50 micrograms or less)

This FDA 510(k) clearance letter for "Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)" does not contain information about software or AI-powered medical devices. Therefore, it does not include acceptance criteria or a study proving that a device meets those criteria in the context of an AI/software device.

The document is for a physical medical device (surgical gloves) and concerns its substantial equivalence to a predicate device based on its physical properties and intended use. The content is typical for a 510(k) clearance for a Class I medical device like gloves, focusing on regulatory compliance rather than performance studies of an AI algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/software device based on the provided text. The prompt's questions (sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth, training set size) are all relevant to the evaluation of AI/software devices, but not to the "Latex Surgical Gloves" discussed in this FDA letter.

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