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A Patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880,6250)

Gloves to be used for protection against chemotherapy drug exposure during use with chemotherapy drug preparation and administration to patients. Chemotherapy drugs tested are: Amethopterin Hydrate, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubincin Hydrochloride, Etoposide, 5-Flourouracil, Paclitaxel, and Vincristine Sulfate.

Nitrile Patient Examination glove , Powder free Glove, Blue color non sterile

The provided text describes a 510(k) summary for a Nitrile Patient Examination Glove Powder-Free (Blue Color) and does not contain information about an AI/ML powered medical device. Therefore, a table of acceptance criteria, device performance, or details regarding a study involving AI/ML performance cannot be extracted or generated based on this document.

The document discusses the physical characteristics and safety testing of the nitrile gloves themselves, ensuring they meet specified ASTM standards and FDA requirements for medical examination gloves and resistance to certain chemotherapy drugs.

Here's why the requested information cannot be provided from the input:

• No AI/ML Device: The entire document pertains to a medical device in the category of "Patient Examination Glove," which is a physical product, not a software algorithm or AI-powered system.
• No Performance Metrics for AI: There are no mentions of metrics like sensitivity, specificity, accuracy, F1-scores, AUC, or any other performance indicators typically associated with AI/ML device evaluation.
• No Study Design for AI: The document does not describe studies involving test sets, training sets, ground truth establishment by experts, adjudication methods, or MRMC comparative effectiveness studies, as these are specific to evaluating AI performance.

The "acceptance criteria" mentioned in the document relate to the physical and chemical properties of the gloves (e.g., dimensions, physical properties, residue powder, freedom from pinholes) and their ability to meet established ASTM and FDA standards for such products.

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