(111 days)
The Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn Blue)
The provided document is a 510(k) Premarket Notification for a Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue). It is not a document detailing the acceptance criteria and study for an AI/ML medical device.
Therefore, the information requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/ML devices is not available in this document.
This document pertains to the regulatory clearance of a physical medical device (gloves) based on substantial equivalence to predicate devices, and its testing involves physical properties like resistance to chemotherapy drugs, not AI/ML performance.
To directly answer your prompt based on the provided document: None of the requested information regarding AI/ML device acceptance criteria and study methods is present.
§ 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.