(100 days)
GLOVMASTER Nitrile Examination Glove Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
GLOVMASTER Nitrile Examination Glove Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
The provided text is a 510(k) summary for the GLOVMASTER Nitrile Examination Glove Powder Free. This document describes the device, its intended use, and comparative data against a predicate device to establish substantial equivalence for regulatory clearance. It does not describe an AI medical device or a study involving AI, nor does it pertain to comparative effectiveness studies involving human readers or expert consensus for ground truth.
Therefore, I cannot extract the information required to answer your request about acceptance criteria and study proving an AI device's performance. The document describes a physical medical device (examination gloves) and its testing for physical and chemical properties, not AI algorithm performance.
To answer your request, you would need to provide a document describing an AI medical device and a study evaluating its performance.
§ 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.