(214 days)
Glove worn on hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Not Found
This document is a 510(k) clearance letter from the FDA for a device described as "Powder Free Latex Examination Gloves." As such, it does not contain any information regarding acceptance criteria, study data, or performance metrics typically associated with AI/ML-driven medical devices.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It does not refer to any studies proving performance against acceptance criteria in the way a modern AI/ML device submission would.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance for a physical medical product based on substantial equivalence, not on validating the performance of an algorithm.
§ 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.