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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.

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This document is a 510(k) premarket notification for patient examination gloves. It approves the device as substantially equivalent to a predicate device. The information provided does not contain details about specific acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device, which is implied by the detailed questions.

Instead, this document pertains to a physical medical device (examination gloves) and its approval process by the FDA based on substantial equivalence. Therefore, I cannot directly answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as they are not applicable to the content of this document.

The document indicates:

• Device Name: Omni Flex Nitrile Examination Glove, Powder Free, Turquoise
• Intended Use: "A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient."
• Regulatory Class: I
• Product Code: LZA
• FDA Action: Substantial Equivalence determination based on comparison to pre-amendment devices, subject to general controls (annual registration, listing, GMP, labeling, prohibitions against misbranding/adulteration).

To answer your specific questions in the context of an AI/ML powered medical device, I would need a different type of document that describes a performance study for such a device.

Ask a specific question about this device