(38 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Nitrile Examination Glove, Powder Free, Green
The provided document is a 510(k) clearance letter from the FDA for a nitrile examination glove. It does not contain information about acceptance criteria for a device, a study proving the device meets those criteria, or details related to AI/algorithm performance.
Therefore, I cannot extract the requested information as it is not present in the document. The document is primarily a regulatory approval notice for a medical device.
§ 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.