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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

Device 2: Halyard Purple Nitrile Powder-Free Exam Glove tested for use with Chemotherapy Drugs and Fentanyl Citrate

Study Information (as applicable to a medical device 510(k) for gloves)

1. Sample size used for the test set and the data provenance:

   • The document implies that testing was done according to the specified ASTM and ISO standards for medical gloves. These standards define the sampling plans (e.g., AQL for holes). Specific sample sizes for each test are not explicitly detailed in this summary but are inherent to the referenced standards.
   • Data Provenance: The tests would have been performed in a laboratory setting to evaluate the physical, chemical, and biocompatibility properties of the gloves. The country of origin of the data is not specified in the document, but it's generated by the manufacturer for regulatory submission in the U.S. (FDA). The nature of the data is quantitative and laboratory-based, not patient (retrospective or prospective) data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For medical gloves, "ground truth" is established by adherence to recognized performance standards (ASTM, ISO). These are engineering and material science tests, not clinical evaluations requiring human expert interpretation in the sense of an AI study (e.g., radiologists interpreting images). The manufacturers' internal quality control and external testing labs are responsible for verifying compliance with these standards.

3. Adjudication method for the test set:

   • Not Applicable. Test results are objective measurements against established standard criteria, not subjective interpretations requiring adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This is a filing for a physical medical device (gloves), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for this device evaluation is adherence to validated industry performance standards (ASTM, ISO) for physical properties, biocompatibility, and chemical permeation resistance. These standards are quantitative and objective.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" in the context of demonstrating equivalence for medical gloves. The manufacturing process and material formulations are continuously "trained" and refined during product development, but this is not data-driven training in the AI sense.

8. How the ground truth for the training set was established:

   • Not Applicable. As above, no training set in the AI sense.

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