(69 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Not Found
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.