(95 days)
A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.
A Colored Nitrile Examination Glove - Powder Free (Blue, Black and White) is a disposable device made of Nitrile latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrile examination glove in the production process to produce the colored gloves.
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML-based medical device. The information requested in your prompt (e.g., sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the development and validation of such AI/ML devices, which is not applicable to a physical medical device like an examination glove.
Therefore, I cannot provide the requested information based on 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.