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Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs and Fentanyl Citrate and Gastric Acid as per ASTM -D6978-05 :

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Azacitidine (25 mg/ml) Bendamustine HCl (5 mg/ml) Bleomycin Sulfate (15 mg/ml) Bortezomib (1 mg/ml) Busulfan (6 mg/ml) Capecitabine (26 mg/ml) Carboplatin (10 mg/ml) Carlzomib (2 mg/ml) Cetuximab (2 mg/ml) Chloroquine (50 mg/ml) Cisplatin (1 mg/ml) Cladribine (1 mg/ml) Cyclophosphamide (20 mg/ml) Cyclosporin A (100 mg/ml) Cytarabine (Cytosine) (100 mg/ml) Cytovene (Ganciclovir) (10 mg/ml) Dacarbazine (DTIC) (10 mg/ml) Dactinomycin (0.5 mg/ml) Daunorubicin HCl (5 mg/ml) Decitabine (5 mg/ml) Docetaxel (10 mg/ml) Doxorubicin HCl (2 mg/ml) Epirubicin HCl (Ellence) (2 mg/ml) Etoposide (Toposar) (20 mg/ml) Fludarabine (25 mg/ml) 5-Fluorouracil (50 mg/ml) Fulvestrant (50 mg/ml) Gemcitabine (38 mg/ml) Idarubicin (1 mg/ml) Ifosfamide (50 mg/ml) Irinotecan HCl (20 mg/ml) Leuprolide Acetate Salt (5 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 (5 mg/ml) Paclitaxel (6 mg/ml) Pemetrexed (25 mg/ml) Raltitrexed (0.5 mg/ml) Retrovir (10 mg/ml) Rituximab (10 mg/ml) Temsirolimus (25 mg/ml) Topotecan HCl (1 mg/ml) Triclosan (2 mg/ml) Trisenox (1 mg/ml) Vinblastine Sulfate (1 mg/ml) Vincristine (1 mg/ml) Vinorelbine (10 mg/ml) Zoledronic Acid (0.8 mg/ml)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes: Carmustine (3.3 mg/ml) No breakthrough up to 55.3 minutes. Thiotepa (10 mg/ml) No breakthrough up to 78.8 minutes. Warning- Not for use with Carmustine and ThioTEPA

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

Fentanyl Citrate Injection (100 mcg/2 ml)

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

The Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable, 9.5 " purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K241909).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Chemotherapy/Hazardous Drug Permeation and Physical Property Tests: The document does not specify the exact sample sizes used for these tests (e.g., number of gloves tested for each drug or physical attribute). The provenance is implied to be laboratory testing conducted by the manufacturer or a contracted lab.
• Low Dermatitis Potential Clinical Test: A 204 subject study was completed. The provenance is from "normal healthy human volunteers," implying a prospective clinical study specifically for this device. The country of origin is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• For the technical and performance testing (ASTM, ISO standards), the "ground truth" is established by the specifications within those recognized standards themselves. The document does not mention the use of experts to establish ground truth for the test set results, but rather relies on the test methods and acceptance criteria defined by the standards.
• For the clinical study on low dermatitis potential, the assessment of "nonirritating" and "no clinical evidence of residual chemical additives that may induce Type IV allergy" serves as the ground truth. This assessment would typically be made by qualified medical professionals (e.g., dermatologists or clinicians experienced in allergy patch testing) overseeing the study, but their specific number and qualifications are not detailed in the provided text.

4. Adjudication Method for the Test Set:

• The document does not describe an explicit adjudication method (like 2+1 or 3+1) for any of the tests. The tests performed are objective laboratory measurements (e.g., breakthrough time, tensile strength, weight of powder, visual inspection for pinholes, and clinical assessment of skin reactions). The results of these tests are directly compared against predefined acceptance criteria. For the clinical study, the "Jordan-King modification of the Draize test as recommended by the FDA" implies a standardized, objective evaluation method for skin irritation and sensitization.

5. 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 device is a medical exam glove, not an AI-powered diagnostic or assistive technology that involves "human readers" or "AI assistance" in the sense of image interpretation or similar cognitive tasks. Therefore, an MRMC comparative effectiveness study regarding improvement with AI assistance is not relevant or described.

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

• Not applicable. This device is a physical medical device (glove), not an algorithm or software.

7. The Type of Ground Truth Used:

• Expert Consensus/Standardized Methods:
  • For the permeation tests, physical properties, pinhole detection, and powder content, the ground truth is based on established industry standards (ASTM, ISO) with defined methodologies and acceptance criteria.
  • For biocompatibility (irritation, systemic toxicity, sensitization), the ground truth is established by the methods outlined in ISO 10993 parts and clinical assessment in the Low Dermatitis Potential study. The clinical assessment is based on observations and evaluations by clinical personnel in accordance with the Modified DRAIZE-95 test.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device (glove) that undergoes laboratory and clinical performance testing, not a machine learning model that requires a training set. The term "training set" is generally used in the context of AI/ML development.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As stated above, this device does not utilize a training set in the AI/ML context.

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