(78 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Nitrile Powder Free Patient Examination Gloves (BLUE), Non-sterile
The provided text is a 510(k) clearance letter from the FDA for Nitrile Examination Gloves Powder Free (Blue). This document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.
The information requested in the prompt is typically found in clinical study reports or performance evaluation documents for AI/ML medical devices, not in a 510(k) clearance letter for a physical medical glove. A 510(k) for a physical device like gloves primarily focuses on demonstrating substantial equivalence to a predicate device, often through physical and chemical testing rather than clinical performance studies with human readers or AI algorithms.
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.