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Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Arsenic Trioxide (1 mg/ml)
• Bendamustine, (5 mg/ml)
• Blenoxane (15 mg/ml)
• Bleomycin (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Carboplatln (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cyclophosphamide (Cytoxan) (20 mg/ml)
• Cytarabine (100 mg/ml)
• Dacarbazine (DTIC) {10 mg/ml)
• Daunorubicin {5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCL (2 mg/ml)
• Ellence (2 mg/ml)
• Erbitux (2 mg/ml)
• Eribilin Mesylate (0.5 mg/ml)
• Etoposide (Toposar) (20 mg/ml)
• Fludarabine (25 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine (Gemzar) (38 mg/ml)
• Idarubicin (1 mg/ml)
• Ifosfamide (IFEX) (50 mg/ml)
• Irinotecan (20 mg/ml)
• Mechlorethamine HCL (1 mg/ml)
• Melphalan (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone (2 mg/ml)
• Oxaliplatin (2 mg/ml)
• Paclitaxel (Taxol) (6 mg/ml)
• Paraplatin (10 mg/ml)
• Pemetrexed Disodium (25 mg/ml)
• Pertuzumab (30 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (Rituxan) (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Thiotepa (10 mg/ml)
• Topotecan HCL (1 mg/ml)
• Trastuzumab (21 mg/ml)
• Trisenox (1 mg/ml)
• Velcade (1 mg/ml)
• Vinblastine (1 mg/ml)
• Vinorelbine (10 mg/ml)

Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)

Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.

The following hazardous drugs and concentration had NO breakthrough detected up to 240 minutes:

• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.

The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.

However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes.

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12" disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that have been tested for use with chemotherapy drugs.

The provided text describes the acceptance criteria and performance data for HALYARD PURPLE NITRILE – XTRA Powder-Free Exam Gloves**, specifically regarding their resistance to chemotherapy drugs and other physical properties.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device