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The Halyard Purple Nitrile, Powder-Free Exam Gloves are disposable devices intended for medical purposes that is 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

No breakthrough was detected up to 240 minutes for Fentanyl Citrate Injection (100 mcg/2 ml) and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The Halyard Purple Powder-Free Nitrile Exam Glove tested with Chemotherapy Drugs, Fentanyl Citrate and simulated Gastric Acid is a disposable, 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 document describes the acceptance criteria and performance data for Halyard Purple Nitrile, Powder-Free Exam Gloves, which are medical gloves, not an AI-powered device. Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, sample size for training set, ground truth for training set) are not applicable to this submission.

The information provided pertains to the physical and chemical performance of the gloves when exposed to certain substances.

Here's a breakdown of the applicable information from the provided document, restructured to address the closest relevant aspects of your request:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test beyond indicating adherence to standard AQLs (Acceptable Quality Levels) for tests like leakage and powder content, which imply a defined statistical sampling plan according to the respective ASTM standards. The provenance of the data is from laboratory testing conducted by the manufacturer, O & M Halyard, Inc., in the context of a 510(k) premarket notification to the FDA. This is inherently prospective testing for a new device submission. Country of origin of the data is not explicitly stated but is implicitly tied to the submitting company (Alpharetta, Georgia, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a physical product being tested against chemical permeation and physical properties, not an AI/algorithm where expert consensus on interpretations is required for ground truth. The "ground truth" here is the objective measurement of chemical breakthrough time, physical dimensions, and material properties according to standardized laboratory protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or adjudication. The tests are objective measurements.

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. No AI component is described in this medical device submission.

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

Not applicable. This is a physical product, not an algorithm.

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

The ground truth used for these tests is based on objective laboratory measurements in accordance with established ASTM and ISO standards for:

• Chemical permeation (breakthrough time of specific drugs through the glove material).
• Physical properties (tensile strength, elongation, dimensions).
• Freedom from defects (pinholes, residual powder).
• Biocompatibility (irritation, systemic toxicity, sensitization).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning model.

9. How the ground truth for the training set was established

Not applicable.

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