(38 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
Not Found
The provided text describes a 510(k) premarket notification for Omni Touch Nitrile Examination Gloves and the FDA's determination of substantial equivalence. It does not contain information about acceptance criteria, device performance metrics, or study details that would typically be found in a clinical trial report or a performance study for an AI/ML device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, ground truth establishment, or multi-reader multi-case studies, as none of this information is present in the provided document.
The document is a regulatory letter from the FDA to OmniGrace (Thailand) Ltd. regarding the clearance of their examination gloves, confirming their substantial equivalence to already marketed devices. It focuses on regulatory compliance rather than performance study results.
§ 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.