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This glove is 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.

The following chemicals have been tested with these gloves.

The tested chemotherapy drugs' breakthrough detection times are listed as follows:

Chemotherapy Drug Minimum BDT
Carmustine, 3.3 mg/ml 16.0 min.
Cisplatin, 1.0 mg/ml >240 min.
Cyclophosphamide (Cytoxan) , 20 mg/ml >240 min.
Doxorubicin Hydrochloride, 2.0 mg/ml >240 min.
Etoposide (Toposar) , 20.0 mg/ml >240 min.
Fluorouracil, 50.0 mg/ml >240 min.
Methotrexate, 25 mg/ml >240 min.
Paclitaxel (Taxol) , 6.0 mg/ml >240 min.
Thiotepa, 10.0 mg/ml 16.6 min.
Vincristine Sulfate, 1.0 mg/ml >>240 min
Please note that the following drugs have extremely low permeation time of less than 30 minutes. Carmustine (3.3 mg/ml) has a minimum breakthrough time of 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 minutes. WARNING: Do not use with Carmustine and Thio-Tepa.

The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of polyisoprene. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.

The provided document describes the acceptance criteria and performance data for "Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use with Chemotherapy Drugs" (K171898) compared to a predicate device, "SensiCare PI Surgical Glove" (K152428).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: The subject device's comparison table explicitly lists only 10 chemotherapy drugs, while the predicate device listing includes an additional 5. However, the overall conclusion of substantial equivalence implies the subject device performs similarly across all relevant criteria that define the predicate. The document states a general conclusion that "The nonclinical testing performed... demonstrates that this device is as safe, as effective, and performs as well as the predicate device".

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes for the individual tests (e.g., number of gloves tested for physical properties, number of permeation tests for each chemotherapy drug).

• Test Set Sample Size: Not explicitly stated for each test.
• Data Provenance: The physical and chemical permeation testing would be conducted in a laboratory setting based on the specified ASTM and ISO standards. The manufacturer, Better Care Plastic Technology Co., Ltd., is located in China, suggesting the testing was likely conducted by or for them, potentially in China or a qualified testing facility. The data appears to be prospective as it was generated to demonstrate compliance for this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable to this type of device. The "ground truth" for surgical gloves and chemotherapy drug permeation is established through validated, standardized laboratory test methods (e.g., ASTM, ISO standards), not through expert consensus or clinical assessment in the same way an AI diagnostic imaging device would have. The "experts" in this context would be the technicians and scientists performing the tests according to the standard protocols.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. For laboratory performance testing of physical properties and chemical resistance, the results are quantitative measurements against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. A MRMC comparative effectiveness study is not applicable to this type of medical device. This is a study design used for diagnostic devices, particularly in imaging, to assess reader performance with and without AI assistance. This document describes laboratory performance testing of a physical barrier device.

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

No. This is not an algorithm or AI device. It's a physical medical device (surgical gloves). The performance tested relates to its physical and chemical barrier properties in a standalone manner (i.e., the glove itself, not with human interaction beyond wearing it).

7. The type of ground truth used:

The "ground truth" for this device's performance is established by objective measurements and validated test methods specified in international standards such as:

• ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
• ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D6978 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
• ISO 10993 series (Biological evaluation of medical devices)

This is a form of objective laboratory data compliant with recognized standards.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, no training set is relevant for this device.

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