(15 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.
Powderfree patient latex examination gloves, with protein label claim ( 50 micrograms or less of total water extractable protein per gram.)
This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. It is a regulatory approval document for a medical device (gloves), not a performance study report for an AI/ML device. Therefore, I cannot extract the requested information from the provided text.
§ 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.