(111 days)
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua 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.
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet 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.
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark 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.
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Dark Violet 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.
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This document is primarily a 510(k) premarket notification letter from the FDA regarding several types of Nitrile Powder Free Examination Gloves. It focuses on the substantial equivalence determination for these gloves and their indication for use with chemotherapy drugs, detailing the breakthrough times for specific drugs.
However, the provided text does not contain any information about an AI/ML powered device, acceptance criteria tests related to such a device, sample sizes for test or training sets, ground truth establishment methods, or multi-reader multi-case (MRMC) comparative effectiveness studies.
The document is solely concerned with the regulatory clearance of medical gloves, which are physical, non-digital medical devices. Therefore, I cannot provide the requested information based on the input 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.