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Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are disposable device 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 as per ASTM-D6978-05: Azacitidine (Vidaza) (25 mg/ml) No breakthrough up to 240 minutes Bendamustine (5 mg/ml) No breakthrough up to 240 minutes Bleomycin sulfate (15 mg/ml) No breakthrough up to 240 minutes Bortezomib (6 mg/ml) No breakthrough up to 240 minutes Busulfan (6 mg/ml) No breakthrough up to 240 minutes Capecitabine (26 mg/ml) No breakthrough up to 240 minutes Carboplatin (10 mg/ml) No breakthrough up to 240 minutes Carfilzomib (2 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) permeation occurred at 59.0 minutes Cetuximab (Erbitux) (2 mg/ml) No breakthrough up to 240 minutes Chloroquine (50 mg/ml) No breakthrough up to 240 minutes Cisplatin (1 mg/ml) No breakthrough up to 240 minutes Cladribine (1.0 mg/ml) No breakthrough up to 240 minutes Cyclophosphamide (20 mg/ml) No breakthrough up to 240 minutes Cyclosporine A (100 mg/ml) No breakthrough up to 240 minutes Cytarabine HCL (100 mg/ml) No breakthrough up to 240 minutes Cytovene (10 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10 mg/ml) No breakthrough up to 240 minutes Dactinomycin (0.5 mg/ml) No breakthrough up to 240 minutes Daunorubicin HCL (5 mg/ml) No breakthrough up to 240 minutes Decitabine (5 mg/ml) No breakthrough up to 240 minutes Docetaxel (10 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCL (2 mg/ml) No breakthrough up to 240 minutes Epirubicin (Ellence) (2 mg/ml) No breakthrough up to 240 minutes Etoposide (20 mg/ml) No breakthrough up to 240 minutes Fludarabine (25 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50 mg/ml) Nobreakthrough up to 240 minutes Fulvestrant (50 mg/ml) No breakthrough up to 240 minutes Gemcitabine (38 mg/ml) No breakthrough up to 240 minutes Idarubicin (1 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50 mg/ml) No breakthrough up to 240 minutes Irinotecan (20 mg/ml) No breakthrough up to 240 minutes Leuprolide acetate salt (5mg/ml) No breakthrough up to 240 minutes Mechlorethamine HCL (1 mg/ml) No breakthrough up to 240 minutes Melphalan (5 mg/ml) No breakthrough up to 240 minutes Methotrexate (25 mg/ml) No breakthrough up to 240 minutes Mitomycin-C (0.5 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2 mg/ml) No breakthrough up to 240 minutes Oxaliplatin (2 mg/ml) No breakthrough up to 240 minutes Paclitaxel (6 mg/ml) No breakthrough up to 240 minutes Pemetrexed (25 mg/ml) No breakthrough up to 240 minutes Raltitrexed (0.5 mg/ml) No breakthrough up to 240 minutes Retrovir (10 mg/ml) No breakthrough up to 240 mimutes Rituximab (10 mg/ml) No breakthrough up to 240 minutes Temsirolimus (25 mg/ml) No breakthrough up to 240 minutes ThioTEPA (10 mg/ml) No breakthrough up to 240 minutes Topotecan HCL (1 mg/ml) No breakthrough up to 240 minutes Triclosan (1 mg/ml) No breakthrough up to 240 minutes Trisenox (0.1 mg/ml) No breakthrough up to 240 minutes Vinblastine (1 mg/ml) No breakthrough up to 240 minutes Vincrinstine Sulfate (1 mg/ml) No breakthrough up to 240 minutes Vinorelbine (10 mg/ml) No breakthrough up to 240 minutes Zoledronic Acid (0.8 mg/ml) No breakthrough up to 240 minutes Fentanyl Citrate Injection, (100mcg /2mL). No breakthrough up to 240 minutes CAUTION: The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes. Carmustine (BCNU): 59 minutes.

The Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs are disposable, pink-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile patient examination gloves.

The document describes the acceptance criteria and performance of the "Halyard Pink Underguard Zero Nitrile Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs" to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for chemotherapy permeation, number of gloves for hole detection). However, it indicates compliance with recognized standards (ASTM, ISO), which typically specify sample size requirements for testing.

The data provenance is from non-clinical tests conducted to evaluate the device's performance against established standards. The country of origin and whether the data is retrospective or prospective are not specified in this document, as these are lab tests, not human studies.

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)

This is a submission for a patient examination glove and involves non-clinical performance and biocompatibility testing. Therefore, there are no "experts" in the sense of clinical reviewers establishing ground truth from medical images or patient data. The "ground truth" is established by the specified test methods and their acceptance criteria within the cited ASTM and ISO standards. The tests are performed by qualified laboratory personnel following these protocols.

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

Not applicable. As this is non-clinical performance testing of a physical device against specified standards, adjudication methods like 2+1 or 3+1 (typically used for clinical or imaging studies) are not relevant. The results are objectively measured and compared to the predefined criteria in the standards.

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 is a submission for a patient examination glove, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant to this type of device.

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

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

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

The "ground truth" for the device's performance is defined by the acceptance criteria specified within the referenced consensus standards:

• ASTM D6978-05 for chemotherapy drug permeation (no breakthrough for a specified time).
• ASTM D5151-06 for detection of holes (2.5% AQL requirement).
• ASTM D6124-06 for residual powder (< 2 mg maximum powder per glove).
• ASTM D6319-10 for physical dimensions and properties (tensile strength, elongation).
• ISO 10993-11, 10993-10 for biocompatibility (non-toxic, non-irritant, non-sensitizer).

These standards provide objective, measurable criteria for the device's performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

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

Not applicable for the reason stated above.

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