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The Halyard Black Fire Powder-Free Nitrile Exam Glove tested with Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The following drugs showed not breakthrough at 240 minutes: Fentanyl Citrate, 100 mcg/2ml.

The Halyard Purple Nitrile Powder-Free Exam Glove tested with Chemotherapy Drugs and Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The following drugs showed not breakthrough at 240 minutes: Bleomycin (15.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin (10.0 mg/ml) Cisplatin (1.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (100.0 mg/ml) Dacarbazine (DTIC) (10.0 mg/ml) Daunorubicin (5.0 mg/ml) Docetaxel (10.0 mg/ml) Doxorubicin Hydrochloride (2.0 mg/ml) Ellence (2.0 mg/ml) Etoposide (Toposar) (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (Gemzar) (38.0 mg/ml) Idarubicin (1.0 mg/ml) Ifosfamide (50.0 mg/ml) Irinotecan (20.0 mg/ml) Mechlorethamine HC1 (1.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (25.0 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone (2.0 mg/ml) Paclitaxel (Taxol) (6.0 mg/ml) Paraplatin (10.0 mg/ml) Rituximab (10.0 mg/ml) Trisonex (1.0 mg/ml) Vincrinstine (1mg/ml) Fentanyl Citrate, 100 mcg/2ml. The following drugs showed breakthrough detected in less than 30 minutes: Carmustine (3.3mg/ml) 1.8 minutes and ThioTEPA (10.0mg/ml): 1.7 minutes. Warning- Not for use with Carmustine and ThioTEPA.

The Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate is a disposable, blackcolored on the grip side and orange colored on the donning side, nitrile, powder- free, textured fingertip, ambidextrous, non-sterile patient examination glove that are chlorinated on the donning side and are packed in a cardboard dispenser box.

The Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate is a disposable, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are chlorinated on the donning side and are packed in a cardboard dispenser box.

This document is a 510(k) premarket notification for medical gloves. It describes the acceptance criteria and performance data for two devices:

• Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate
• Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate

The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove an AI model's performance. Therefore, many of the requested items related to AI/MRMC studies, expert adjudication, and ground truth establishment for AI models are not applicable to this document.

However, I can extract the acceptance criteria and device performance as reported for these specific medical devices based on the provided text.

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves. The performance data presented demonstrates that the subject devices meet these standards and are substantially equivalent to their predicate devices.

Device 1: Halyard Black-Fire Powder-Free Nitrile Exam Glove tested for use with Fentanyl Citrate

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