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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small. Medium. Large. Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.

The acceptance criteria for the Biodegradable Nitrile Powder Free Examination Gloves and their reported performance are detailed in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes for each test mentioned (e.g., number of gloves tested for each specific drug permeation, or for physical properties). However, it references established ASTM and ISO standards for these tests. These standards typically define the sampling plans and statistical requirements for demonstrating compliance. The data provenance is derived from non-clinical laboratory testing (in-vitro studies) performed by the manufacturer or a contracted lab, rather than human test subjects or clinical data. There is no information on the country of origin of the data.

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

This section is not applicable. The device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biological tests (e.g., ASTM D6319, ASTM D6978, ISO 10993 series). The "ground truth" for these tests is established by the well-defined methodologies and acceptance criteria outlined in these international standards, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation tasks where human readers' opinions are combined to establish a ground truth. For the non-clinical performance testing of a medical device like examination gloves, the determination of compliance is based on objective measurements against established standard criteria, not on adjudicating expert opinions.

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

This section is not applicable. No MRMC study was conducted as this device is an examination glove, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This section is not applicable. The device is an examination glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used

The "ground truth" for the performance evaluation of these gloves is based on standardized test methodologies and their defined acceptance criteria. This includes:

• Physical performance standards: ASTM D6319-19 for mechanical properties like length, palm width, thickness, tensile strength, and elongation.
• Leakage detection standards: ASTM D5151-19 for watertight integrity.
• Chemical permeation standards: ASTM D6978-05 (2019) for breakthrough detection time of chemotherapy drugs and other chemicals.
• Biocompatibility standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (skin irritation).

These standards provide objective, measurable criteria for the device's performance.

8. The sample size for the training set

This section is not applicable. The document describes the non-clinical performance testing of a physical medical device (examination gloves), not an AI or machine learning model. Therefore, there is no concept of a "training set" for an algorithm.

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

This section is not applicable, as there is no training set for this device.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property tested per ASTM D5511. Biodegradability is not a medical claim and therefore was not reviewed by the FDA.

This document is a 510(k) summary for the Syntex Healthcare Products Co., Ltd.'s "Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

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

The device's performance is primarily evaluated against recognized standards for medical examination gloves and specific tests for chemical permeation.

Note on Chemotherapy Permeation: For Carmustine and Thio Tepa, the reported breakthrough detection times (12.9 minutes and 35.6 minutes respectively) are explicitly noted as "extremely low permeation times" and a warning is issued: "Do not use with Carmustine and Thio Tepa." This indicates that for these specific drugs, the device does not meet an implicit "long duration" acceptance criterion and thus, limitations are clearly stated for safe use.

The study that proves the device meets (or defines limitations for) these criteria is a Summary of Non-Clinical Performance Data (Section 7 and 10 of the provided document).

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., number of gloves for physical dimensions, individual tests for chemotherapy permeation, or biological evaluations). However, the tests are performed according to recognized international standards (ASTM and ISO), which typically specify appropriate sample sizes for testing to ensure statistical validity.

The data provenance is from Syntex Healthcare Products Co., Ltd., located at No. 1, Fanjiazhuang Industrial Zone, Xinji City, Hebei Province, 052360, China. These are retrospective tests conducted by the manufacturer as part of the premarket notification (510(k)) submission process.

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

This information is not provided in the document. For non-clinical performance data like material testing and chemical permeation, "experts" in the sense of clinical decision-makers (e.g., radiologists) are not typically involved in establishing ground truth. The ground truth is objective, defined by the parameters of the test methods (e.g., measuring glove dimensions, detecting chemical breakthrough, evaluating cellular response). The tests are performed by personnel trained in the specific methodologies, likely in a laboratory setting.

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

An adjudication method (like 2+1, 3+1) is relevant for studies involving human interpretation or subjective assessments, often when establishing a ground truth from multiple reviewers. Since these are non-clinical laboratory tests with objectively measurable outcomes (e.g., min/mm measurements, detection of chemical permeation, biological response), an adjudication method is not applicable and therefore, none was used. The "ground truth" is determined by the direct results of the standardized tests.

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:

No MRMC comparative effectiveness study was done. This type of study is completely irrelevant for a medical device such as examination gloves, which do not involve human readers or AI assistance in their function or evaluation.

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

No standalone algorithm-only performance assessment was done. This device is an examination glove, not an AI or software-based medical device.

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

The ground truth for the non-clinical tests is based on objective measurements and observations according to established ASTM and ISO standards and methodologies.

• Physical properties and dimensions: Direct physical measurements.
• Chemical permeation: Detection of the breakthrough of specific chemicals through the glove material using analytical methods defined in ASTM D6978-05 (2019).
• Biocompatibility: In vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) tests with defined endpoints and criteria.
• Bioburden: Microbiological testing to quantify microorganism levels.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning device, so there is no "training set." The data presented is from non-clinical performance testing of the final product.

9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply here.

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