(38 days)
The medical gloves are worn on the hands of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Nitrile Powder Free Patient Examination Gloves
This document is a 510(k) clearance letter from the FDA for Nitrile Powder Free Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance in the context of medical devices that typically involve AI or complex algorithms.
The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This determination is based on the device meeting general controls provisions and Good Manufacturing Practice (GMP) regulations, not on specific performance metrics from a clinical study as would be described for an AI-powered diagnostic device.
Therefore, I cannot provide the requested information from the provided document.
§ 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.