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A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating and is yellow in color.

The glove are manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only.

The provided document describes the acceptance criteria and the study for "Cardinal Health™ Sterile Neoprene Powder-free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)." This is a medical device, specifically a surgical glove, and the study focuses on its physical properties, biocompatibility, and resistance to chemotherapy drug permeation. There is no AI component mentioned in this documentation, therefore, several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training) are not applicable.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against various standards, primarily ASTM D3577 for surgical gloves and ASTM D6978 for chemotherapy drug permeation.

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These powder-free sterile light brown colored surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in
Minutes, 0.01 µg/cm²/minute |
|-----|-------------------------------------|-----------------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.20 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (20 mg/ml) | >240 |
| 6. | Fluorouracil (50.0 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10.0 mg/ml) | 82.2 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating. The gloves are manufactured using exact same material used in the currently cleared device, Duraprene SMT gloves, that have been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.

The acceptance criteria and device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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These powder-free sterile surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Gloves are formulated using neoprene. They are coated with nitrile coating and are offered powder-free and sterile.

Here's a breakdown of the acceptance criteria and the study information for the Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating, based on the provided text:

Based on the provided 510(k) summary, this document describes a device for general medical use (surgical gloves), not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies, such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and how ground truth was established, are not applicable to this submission. The "study" here refers to standard performance testing for medical gloves.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating

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

• Sample Size for Test Set: Not explicitly stated for each test. Testing for medical gloves typically involves sampling a certain number of gloves from production lots according to relevant ASTM standards (e.g., ASTM D3577 for physical properties and freedom from holes, ASTM D6124 for powder residual).
• Data Provenance: The manufacturing location is listed as "7/111 Moo 4, Highway 331 Mabyangporn Pluakdaeng, Rayong, 21140, Thailand." The data is likely prospective testing performed on manufactured gloves.

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

• Not Applicable. This is not an AI/ML device where expert ground truth is established in the same manner. The "ground truth" for glove performance is determined by adherence to established governmental regulations (21 CFR 800.20) and industry standards (ASTM D3577, ASTM D6124), often through instrumental measurements and standardized methods rather than expert consensus on complex interpretations.

4. Adjudication method for the test set

• Not Applicable. No adjudication method, such as 2+1 or 3+1, is mentioned or would be relevant for these types of physical and chemical tests on surgical gloves. Performance is assessed against quantitative thresholds defined by 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 not an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used

• The ground truth for this device is based on established regulatory requirements (21 CFR 800.20) and recognized industry performance standards (ASTM D3577, ASTM D6124). These standards define the acceptable range or threshold for specific physical and chemical properties of the gloves.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. This is not an AI/ML device.

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