(57 days)
mCare® Powder Free Nitrile Orange Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
mCare® Powder Free Nitrile Orange Examination Gloves
This document is a 510(k) clearance letter from the FDA for a medical device: "mCare® Powder Free Nitrile Orange Examination Gloves."
This document does not contain information regarding acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/ML medical device. It is a regulatory clearance for a physical product (gloves).
Therefore, I cannot extract the requested information as it is not present in 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.