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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Safety Powdered Blue Latex Examination Gloves

This appears to be a 510(k) clearance letter from the FDA for medical gloves, not a study describing the acceptance criteria or performance of a medical device in the way a diagnostic or AI-based device would be evaluated. The text pertains to regulatory classification and the ability to market the device, based on substantial equivalence to a predicate device.

Therefore, the requested information elements (1-9) which are typically Tused for describing the performance study of a diagnostic device or an AI algorithm, cannot be extracted from this document. The document primarily focuses on regulatory approval based on "substantial equivalence" for a Class I medical device (gloves), rather than detailed performance metrics or clinical study results as would be the case for higher-risk devices or software.

In essence:

• There's no mention of specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for the gloves in the provided text. The "acceptance" here relates to regulatory clearance based on substantial equivalence.
• There is no study described in the document that investigates device performance using a test set, ground truth, experts, or statistical analysis (like MRMC studies or standalone performance).

The "performance" implied for these gloves would be things like barrier integrity, tear resistance, and biocompatibility, which are typically assessed through recognized consensus standards or internal company testing, but these reports are not part of the provided FDA letter.

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