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The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, 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 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:

• 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)
• Carfilzomib (2 mg/ml)
• Cetuximab (2 mg/ml)
• Cisplatin (1 mg/ml)
• Cladribine (1 mg/ml)
• Cyclophosphamide (20 mg/ml)
• Cytarabine HCl (100 mg/ml)
• Dacarbazine (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 (2 mg/ml)
• Etoposide (20 mg/ml)
• Fludarabine Phosphate (25 mg/ml)
• Fluorouracil (50 mg/ml)
• Fulvestrant (50 mg/ml)
• Gemcitabine HCl (38 mg/ml)
• Idarubicin HCl (1 mg/ml)
• Ifosfamide (50 mg/ml)
• Irinotecan HCl (20 mg/ml)
• Leuprolide Acetate (5 mg/ml)
• Mechlorethamine HCl (1 mg/ml)
• Melphalan HCl (5 mg/ml)
• Methotrexate (25 mg/ml)
• Mitomycin C (0.5 mg/ml)
• Mitoxantrone HCl (2 mg/ml)
• Oxaliplatin (5 mg/ml)
• Paclitaxel (6 mg/ml)
• Pemetrexed (25 mg/ml)
• Raltitrexed (0.5 mg/ml)
• Rituximab (10 mg/ml)
• Temsirolimus (25 mg/ml)
• Topotecan HCl (1 mg/ml)
• Trisenox (Arsenic Trioxide) (1 mg/ml)
• Vinblastine Sulfate (1 mg/ml)
• Vincristine (1 mg/ml)
• Vinorelbine Tartrate (10 mg/ml)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 100 minutes:

• Carmustine (3.3 mg/ml) No breakthrough up to 44.5 minutes.
• Thiotepa (10 mg/ml) No breakthrough up to 99.1 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

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

• Chloroquine (50 mg/ml)
• Cyclosporin A (100 mg/ml)
• Cytovene (10 mg/ml)
• Retrovir (10 mg/ml)
• Triclosan (2 mg/ml)
• Zoledronic Acid (0.8 mg/ml)

The Halyard Purple Nitrile* Powder‐Free Exam Gloves, Sterile Pairs or Sterile Singles, 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, sterile patient examination gloves.

The provided text is a 510(k) clearance letter and summary for medical examination gloves, not an AI/ML device. Therefore, it does not contain information related to AI/ML specific acceptance criteria or study details such as:

• Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on the physical and chemical properties of the gloves and their resistance to various chemicals, using established ASTM and ISO standards for medical gloves.

However, I can extract the acceptance criteria and reported device performance for these medical gloves based on the provided document.

Analysis of Acceptance Criteria and Device Performance for Medical Gloves

The document details the non-clinical testing performed on the Halyard Purple Nitrile* Powder-Free Exam Gloves to demonstrate their safety and effectiveness. The acceptance criteria and the results of these tests are clearly outlined.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that testing was performed according to specific ASTM and ISO standards (e.g., ASTM D6978-05, ASTM D5151, ASTM D6124, ASTM D6319, ISO 10993 Parts 10, 11, 23, ANSI/AAMI/ISO 11137). These standards inherently define the sample sizes and methodologies for testing. For instance, AQL (Acceptable Quality Level) values like 2.5% and 4.0% are mentioned for pinholes and physical properties, which dictates sampling plans for quality control.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of an AI/ML study. It is implied to be laboratory testing data generated prospectively for the purpose of this 510(k) submission, confirming product specifications.

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

This is not applicable to the evaluation of medical gloves. The "ground truth" for glove performance is established by adherence to recognized international standards (ASTM, ISO, ANSI/AAMI) for physical, chemical permeation, and biocompatibility testing, rather than expert human interpretation of medical images or data. The testing is objective and quantitative.

4. Adjudication method for the test set

Not applicable. Testing involves standardized objective measurements, not subjective human evaluations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are relevant for imaging diagnostics or other AI/ML applications where human interpretation is a key component. This document describes the testing of a physical medical device.

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

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

7. The type of ground truth used

The "ground truth" used is defined by the objective measurement criteria and methodologies specified in the cited international standards (ASTM D6978-05, ASTM D5151, ASTM D6319, ASTM D6124, ISO 10993, ANSI/AAMI/ISO 11137). For example, for chemical permeation, the ground truth is the chemical breakthrough time measured according to ASTM D6978-05. For biocompatibility, it's the observed biological reactions in animal models or in vitro tests compared to established toxicity/irritation/sensitization thresholds.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. As above, this document describes a physical medical device, not an AI/ML system.

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Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, 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 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: Cisplatin. 1 mg/ml Cyclophosphamide, 20 mg/ml Dacarbazine, 10 mg/ml Doxorubicin HCl. 2 mg/ml Etoposide, 20 mg/ml Fluorouracil. 50 mg/ml lfosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes.

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes.

Warning: Not for use with Carmustine, Thiotepa

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

Fentanyl Citrate Injection (50 mcg/5 ml)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile, powder-free, textured, ambidextrous, non-sterile patient examination glove that is packed in a cardboard dispenser box.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Halyard Black Nitrile Powder-Free Exam Gloves.

Based on the provided K242558 510(k) summary, the device is a medical glove, and the studies performed are non-clinical, primarily focused on physical properties, biocompatibility, and resistance to chemical permeation. This is not a study assessing AI performance or human reader effectiveness.

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

   • The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for pinholes, number of samples per drug for permeation). However, all tests are performed according to recognized ASTM and ISO standards, which typically specify statistically significant sample sizes for their respective tests.
   • Data Provenance: The studies are non-clinical (laboratory-based) performance and biocompatibility tests conducted by the manufacturer (O&M Halyard, Inc.). The country of origin of the data is not specified but is implicitly associated with the manufacturer's testing facilities. The studies are prospective in nature, meaning they were designed and executed to evaluate the device's performance against defined criteria.

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

   • Not applicable. This is a non-clinical device that relies on a pass/fail outcome against established engineering and biocompatibility standards, not expert interpretation of medical images or biological samples. The "ground truth" is determined by the results of the specified physical and chemical tests.

3. Adjudication method for the test set:

   • Not applicable. As this involves objective, quantifiable laboratory tests against defined numerical criteria (e.g., specific tensile strength, elongation percentages, lack of leakage, breakthrough times), there is no need for expert adjudication. The results are directly compared to the acceptance criteria.

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 device is a medical examination glove, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed, and thus no effect size for AI assistance is relevant.

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

   • Not applicable. This device is a physical product (a glove), not an algorithm or software. Its performance is evaluated through physical and chemical testing.

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

   • The "ground truth" for this device's performance is based on established industry standards and regulatory requirements (e.g., ASTM and ISO standards). For example, for "Freedom from Pinholes," the ground truth is "no leakage" at an AQL 2.5%, determined by empirical testing methods defined in ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time for each specific drug, evaluated against a performance threshold (e.g., >240 minutes for no breakthrough).

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.

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

   • Not applicable, as there is no training set for this device.

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