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THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

The tested chemotherapy drugs and permeation times are as follows:

Bleomycin Sulfate 15 mg/mL. >240 minutes Busulfan 6 mg/mL, >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 23.5 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL. >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) IO mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel IO mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL, >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes Bendamustine (5.0 mg / ml), > 240 minutes Oxaliplatin (5.0 mg / ml), > 240 minutes Azacitidine (Vidaza] (25.0 mg / ml) ,> 240 minutes Capecitabine (26.0 mg / ml), > 240 minutes Cladribine (1.0 mg / ml), > 240 minutes Decitabine (5.0 mg / ml) ,> 240 minutes Pemetrexed (25.0 mg / ml), > 240 minutes Raltitrexed (0.5 mg / ml), > 240 minutes Actinomycin D (0.5mg / ml)(Dactinomycin), > 240 minutes Vinorelbine (10.0 mg / ml), > 240 minutes Vinblastine (1.0 mg / ml), > 240 minutes

Fentanyl tested as follows; Fentanyl citrate 100 mcg/2mL. >240 minutes

WARNING: Not for use with Carmustine or Thiotepa.

lfosfamide 50 mg/mL. >240 minutes Irinotecan 20 mg/mL. >240 minutes Mechlorethamine I mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL. >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL. >240 minutes Thiotepa 10 mg/mL, 37.9 minutes Trisenox 1 mg/mL . >240 minutes Vincristine Sulfate I mg/mL, >240 minutes Topotecan (1.0 mg / ml), >240 minutes Carfilzomib (2.0 mg / ml), >240 minutes Cetuximab [Erbitux] (2.0 mg / ml), > 240 minutes Temsirolimus (25.0 mg / ml), > 240 minutes Bortezomib [Velcade] (1.0 mg / ml), > 240 minutes Fulvestrant (50.0mg / ml),> 240 minutes Leuprorelin acetate (5.0 mg / ml), > 240 minutes Ganciclovir [Cytovene] (10.0 mg / ml), > 240 minutes Zidopusin (Retrovir) (10.0 mg / ml), > 240 minutes Zoledronic acid (0.8 mg / ml), > 240 minutes Triclosan (3.0 mg / ml), > 240 minutes Chloroquine (50.0 mg / ml), > 240 minutes Cyclosporine A (100.0 mg / ml) , > 240 minutes Propofol (10 mg/ml) (Diprivan), > 240 minutes MESNA (100 mg/ml), > 240 minutes

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl-Blue. THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

The provided text is a 510(k) premarket notification letter from the FDA regarding a non-sterile, powder-free nitrile examination glove. It does not contain information about acceptance criteria or a study proving device performance for an AI/ML powered medical device.

The information primarily focuses on the regulatory classification, general controls, and indications for use of the examination gloves, including their permeation times for various chemotherapy drugs and fentanyl.

Therefore, I cannot provide the requested information about acceptance criteria and a study for an AI/ML device based on the given input.

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