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The Disposable Vinyl Glove is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided text describes a 510(k) premarket notification for a Disposable Vinyl Glove. This document demonstrates the substantial equivalence of the subject device to a legally marketed predicate device, rather than proving that an AI/ML medical device meets specific acceptance criteria through a study with outlined performance metrics.

Therefore, I cannot extract the acceptance criteria and study details for an AI/ML device from the provided text.

The document discusses:

• The device: Disposable Vinyl Glove.
• Its intended use: for medical purposes, worn on examiner's hands to prevent contamination.
• Its classification: Class I, patient examination glove.
• Comparison to a predicate device (Hebei Hongtai Plastic Products Company Limited Vinyl Patient Examination Gloves).
• Non-clinical tests performed:
  • Biocompatibility (Irritation, Sensitization, Cytotoxicity) to ISO 10993-10:2010 and ISO 10993-5:2009.
  • Physical properties (Tensile Strength, Ultimate Elongation, Freedom from Holes, Powder Content) to ASTM D5250-19, ASTM D5151-06, and ASTM D6124-06.

None of these tests involve AI/ML performance metrics, a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance.

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