(154 days)
A 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. Tested for use with the following Chemotherapy Drugs: Cisplatinum, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, 5-Flourouracil, Methotrexate & Paciitaxel.
BioClean Chemo Emerald Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Sterile)
This letter from the FDA pertains to the clearance of a medical device, specifically "BioClean Chemo Emerald Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Sterile)". It is a 510(k) premarket notification, which means the manufacturer demonstrated substantial equivalence to a legally marketed predicate device.
The document does not provide details about acceptance criteria, a specific study proving the device meets these criteria, or any of the detailed information requested in points 1-9 regarding an AI/algorithm-driven device study.
This letter is a regulatory clearance for a physical medical glove and does not describe an AI/software device or its performance study.
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.