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The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:

• Carmustine (BiCNU);
• Cyclophosphamide;
• Doxorubicin Hydrochloride;
• 5-Fluorouracil;
• Cisplatin;
• Etoposide;
• Paclitaxel:
• Thio-Tepa
• Dacarbazine

The device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:

• Carmustine (BiCNU);
• Cyclophosphamide;
• Doxorubicin Hydrochloride;
• 5-Fluorouracil;
• Cisplatin;
• Etoposide;
• Paclitaxel:
• Thio-Tepa
• Dacarbazine

The provided document is a 510(k) clearance letter from the FDA for "Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemo Therapy Drugs". This document does not contain any information about acceptance criteria or a study proving device performance related to an AI/ML context.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices, allowing the manufacturer to market it. The "acceptance criteria" mentioned in the request refer to performance metrics typically used for AI/ML devices (e.g., sensitivity, specificity, AUC), while this document is for a physical medical glove.

Therefore, I cannot extract the requested information from this document.

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