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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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This powder-free 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 m and the most go res world of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, it is formulated from polyisoprene, which is a synthetic rubber latex. This Sterile Polyisoprene Powder-Free Surgical Glove is manufactured using exact same material used in the currently cleared device, Esteem SMT glove (K093300) that has been legally marketed by Cardinal Health. The glove is manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. It is offered powder-free and sterile.

The provided document describes the safety and effectiveness summary for "Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs." This is for a medical device and not an AI or software device, therefore, the requested information elements related to AI/algorithm performance studies like sample size for test/training sets, data provenance, number/qualification of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable.

The acceptance criteria and the study proving the device meets these criteria are related to the physical, chemical, and biological properties of the surgical gloves.

1. A table of acceptance criteria and the reported device performance

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for holes, or how many samples for biocompatibility). However, the tests were conducted according to recognized international and national standards (e.g., ISO 10993, ASTM D3577, ASTM D6978, 21 CFR 800.20), which typically specify appropriate sample sizes and methodologies.

The "data provenance" for this type of device (surgical gloves) would relate to the manufacturing and testing environment, not patient data. The tests are non-clinical, laboratory-based studies.

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

Not applicable. For surgical glove testing, "ground truth" is established by adherence to standardized test methods and criteria defined by organizations like ASTM and ISO, not by expert human consensus on medical images or diagnoses.

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

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or for AI output evaluation. The tests performed for these gloves (e.g., physical properties, chemical permeation) are objective laboratory measurements, not requiring adjudication.

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 device is a physical medical glove, not an AI or imaging diagnostic tool.

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

Not applicable. This device is a physical medical glove, not an AI or algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective laboratory measurements and adherence to predefined specifications and test standards. For example:

• Biocompatibility: Determined by standardized in-vivo (e.g., guinea pig maximization) and in-vitro tests following ISO 10993.
• Physical Properties: Measured against specifications in ASTM D3577.
• Freedom from Holes: Determined by testing according to ASTM D5151 and meeting AQL (Acceptable Quality Level) requirements specified in 21 CFR 800.20 & ASTM D3577.
• Powder Residual: Measured using ASTM D6124 to meet ASTM D3577 limits.
• Chemotherapy Drug Permeation: Measured as breakthrough time using ASTM D6978.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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