(42 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Latex Examination Gloves, Powdered Contains 180 mcgm or less of Total Water Extractable Protein per gram.
This document is a 510(k) premarket notification letter from the FDA to Arista Latindo Industrial Limited for their Latex Examination Gloves, Powdered. It confirms the device's substantial equivalence to a legally marketed predicate device.
This document does not contain information related to acceptance criteria or a study proving a device meets acceptance criteria for an AI/ML medical device.
The provided text discusses general regulatory compliance for medical devices (registration, labeling, manufacturing practices) and does not include details about performance criteria, sample sizes for testing, ground truth establishment, or any studies involving AI. Therefore, I cannot extract the requested information as it is not present in the input.
§ 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.