(13 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Not Found
The provided text is a 510(k) clearance letter for the "Syntex Powder-Free Nitrile Examination Glove." This document focuses on the regulatory clearance for a medical glove, not on the performance of a diagnostic or AI-driven device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and comparative effectiveness studies is not present in the provided text.
The document states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the device was cleared because it was found to be as safe and effective as an existing, legally marketed device, not through a study involving the kind of detailed performance metrics as would be required for an AI or diagnostic device.
The "Indications For Use" section on page 3 succinctly describes the intended purpose of the glove: "A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment." This is a functional description, not a set of performance criteria with quantitative targets.
§ 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.