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This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This device has been tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

The tested chemotherapy drugs are as follows:

Carmustine (BCNU) 3.3 mg/mL, 12.8 minutes breakthrough detection time
Cisplatin 1.0 mg/mL, No breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, No breakthrough up to 240 minutes
Dacarbazine (DTIC) 10.0 mg/mL, No breakthrough up to 240 minutes
Doxorubicin Hydrochloride 2.0 mg/mL, No breakthrough up to 240 minutes
Etoposide (Toposar) 20.0 mg/mL, No breakthrough up to 240 minutes
Fluorouracil 50.0 mg/mL, No breakthrough up to 240 minutes
Methotrexate 25 mg/mL, No breakthrough up to 240 minutes
Paclitaxel (Taxol) 6.0 mg/mL, No breakthrough up to 240 minutes
Thiotepa 10.0 mg/mL, 4.5 minutes breakthrough detection time
Vincristine Sulfate 1.0 mg/mL, No breakthrough up to 240 minutes

CAUTION: Carmustine and Thiotepa have low breakthrough times of 12.8 and 4.5 minutes respectively.

Non-sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs

This document is a 510(k) clearance letter from the FDA for a Non-Sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs.

The request asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specific details about MRMC studies, ground truth establishment, sample sizes, and expert qualifications.

However, the provided document does not contain information related to an AI/ML medical device or a diagnostic study involving human readers or algorithms. It is a regulatory clearance letter for a physical medical device (examination gloves). Therefore, I cannot extract the requested information about acceptance criteria, study details, human-in-the-loop performance, or AI model training from this document.

The document focuses on:

• Device Name: Non-Sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs
• Regulation Number: 21 CFR 880.6250 (Non-Powdered Patient Examination Glove)
• Regulatory Class: Class I
• Indications for Use: Disposable device for medical purposes worn on examiner's hand to prevent contamination between patient and examiner. Specifically tested for use with Chemotherapy Drugs as per ASTM D6978-05.
• Chemotherapy Drugs Tested: Lists 11 specific chemotherapy drugs and their breakthrough detection times.
• Caution: Highlights low breakthrough times for Carmustine and Thiotepa.

Therefore, I cannot fulfill the request as it pertains to AI/ML device studies using this specific document.

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