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Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

• Arsenic Trioxide (1 mg/ml)
• Bendamustine, (5 mg/ml)
• Blenoxane (15 mg/ml)
• Bleomycin (15 mg/ml)
• Bortezomib (1 mg/ml)
• Busulfan (6 mg/ml)
• Carboplatln (10 mg/ml)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cyclophosphamide (Cytoxan) (20 mg/ml)
• Cytarabine (100 mg/ml)
• Dacarbazine (DTIC) {10 mg/ml)
• Daunorubicin {5 mg/ml)
• Decitabine (5 mg/ml)
• Docetaxel (10 mg/ml)
• Doxorubicin HCL (2 mg/ml)
• Ellence (2 mg/ml)
• Erbitux (2 mg/ml)
• Eribilin Mesylate (0.5 mg/ml)
• Etoposide (Toposar) (20 mg/ml)
• Fludarabine (25 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine (Gemzar) (38 mg/ml)
• Idarubicin (1 mg/ml)
• Ifosfamide (IFEX) (50 mg/ml)
• Irinotecan (20 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 (2 mg/ml)
• Paclitaxel (Taxol) (6 mg/ml)
• Paraplatin (10 mg/ml)
• Pemetrexed Disodium (25 mg/ml)
• Pertuzumab (30 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (Rituxan) (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Thiotepa (10 mg/ml)
• Topotecan HCL (1 mg/ml)
• Trastuzumab (21 mg/ml)
• Trisenox (1 mg/ml)
• Velcade (1 mg/ml)
• Vinblastine (1 mg/ml)
• Vinorelbine (10 mg/ml)

Carmustine (3.3 mg/ml) permeation occurred at 60.0 minutes.

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

• Fentanyl Citrate Injection (100 mcg/2 ml)
• Gastric Acid Fluid/Fentanyl Citrate Injection Mix (50/50 Solution)

Caution: Testing showed a minimum breakthrough time of 60.0 minutes with Carmustine.

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

• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid are disposable, 12"purple-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, nonsterile patient examination gloves.

The provided text is an FDA 510(k) clearance letter and summary for a medical glove, not an AI-powered medical device. Therefore, many of the requested fields related to AI study design (like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "number of experts," etc.) are not applicable and cannot be found in the document.

However, I can extract the acceptance criteria and performance data for the glove based on the provided information, focusing on the non-clinical and clinical tests described.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Chemotherapy and Hazardous Drug Permeation (ASTM D6978-05): The document does not specify the exact sample size (number of gloves/runs per drug) for the permeation tests. The data provenance is not specified, but it would have been generated from laboratory testing of the manufactured gloves.
• Biocompatibility (ISO 10993 parts 10, 11, 23): "No animals" for systemic toxicity implies a small animal study; the exact number is not stated. For irritation, an animal study is also implied. For skin sensitization, the "Grade < 1.0" implies a quantitative assessment from an animal study. Data provenance is laboratory testing.
• Physical Properties (ASTM D6319, D5151, D6124): These standards typically involve statistical sampling plans for testing batches of gloves (e.g., AQL levels). The exact number of gloves tested is not explicitly stated in the summary but assumes testing according to the standards. Data provenance is laboratory testing.
• Modified DRAIZE-95 Test (Low Dermatitis Potential):
  • Sample Size: 204 human subjects.
  • Data Provenance: Prospective human clinical study. The country of origin is not specified, but these types of studies for FDA clearance are generally conducted under U.S. or international clinical study guidelines.

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

Not applicable. This device is a physical medical glove undergoing non-clinical and a small clinical study, not an AI/software device requiring expert interpretation for ground truth. The "ground truth" here is objective laboratory measurements (e.g., breakthrough time, physical dimensions, chemical residues) and clinical observations of skin reactions.

4. Adjudication method for the test set

Not applicable. For laboratory tests, results are typically determined by instrumental readings and standard protocols. For the human clinical study, it would involve direct observation and assessment by trained clinical personnel (e.g., dermatologists or nurses) of skin reactions, but an explicit adjudication method (like 2+1) usually associated with image interpretation is not mentioned.

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 not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

• Chemotherapy and Hazardous Drug Permeation: Objective measurement of chemical permeation/breakthrough time using analytical techniques (e.g., gas chromatography).
• Biocompatibility: Objective biological responses in animal models (e.g., presence/absence of toxicity, irritation, sensitization).
• Physical Properties: Objective measurements (e.g., length, width, thickness, tensile strength, elongation, powder amount) and qualitative assessment for pinholes (e.g., water leak test).
• Modified DRAIZE-95 Test: Clinical observations by dermatological or trained personnel of skin irritation and allergic reactions in human subjects.

8. The sample size for the training set

Not applicable. The glove's performance is not determined by a "training set" in the context of machine learning. The manufacturing process is refined based on quality control and adherence to standards, but there isn't a "training set" like in AI.

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

Not applicable. As above, there is no "training set" for this type of medical device clearance.

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