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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 23.7 Minutes Thio-Tepa 10.0 mg/ml 45.7 Minutes

Caution: Testing showed an average breakthrough time of 45.7 minutes with Thio-Tepa

WARNING: Do not use with Carmustine

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered non-sterile and in five sizes: extra-small, small, medium, large, and extra-large.

Below is a summary of the acceptance criteria and the study conducted for the Disposable Nitrile Examination Glove, as detailed in the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides sample sizes for specific tests:

• ASTM D5151 (Watertightness): 125 gloves per size (XS, S, M, L, XL) were tested.
• The specific sample sizes for other tests like physical dimensions (ASTM D6319, ASTM D412), powder content (ASTM D6124), chemotherapy drug permeation (ASTM D6978), and biocompatibility (ISO 10993-5, ISO 10993-10) are not explicitly stated in numerical terms (e.g., "n=X"), but are implied to be sufficient to meet the requirements of the respective ASTM and ISO standards.
• Data Provenance: The studies were conducted by the device manufacturer, Inner Mongolia Boming Medical Supplies Co., Ltd., which is located in China. The data would be considered prospective as it involves new testing on the subject device to demonstrate its performance against established standards.

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

This information is not applicable to this device. The "ground truth" for the performance of examination gloves is established by objective, standardized laboratory tests (e.g., ASTM and ISO methods) rather than expert clinical judgment or consensus. These are physical and chemical properties measured according to specific protocols.

4. Adjudication Method for the Test Set:

This is not applicable to this device. As mentioned above, the evaluation relies on objective measurements from standardized test methods, not subjective assessments requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or other complex data, and their performance is compared with and without AI assistance. Examination gloves are a Class I device with performance assessed via bench testing, not human interpretation.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination glove), not an AI algorithm or software. Its performance is evaluated through material and physical property testing, not algorithmic output.

7. Type of Ground Truth Used:

The ground truth used in these studies is based on objective, quantitative measurements obtained through validated and standardized laboratory test methods as defined by:

• ASTM International (formerly American Society for Testing and Materials) standards: ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978.
• ISO (International Organization for Standardization) standards: ISO 10993-5 and ISO 10993-10.
  These standards define the methods for measuring physical properties, chemical resistance, and biocompatibility, and the "ground truth" is the result of these measurements compared against the specified acceptance criteria within the standard.

8. Sample Size for the Training Set:

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" of data. The manufacturing process of examination gloves is based on established engineering principles and quality control, rather than machine learning models.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no "training set" for this device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.

The provided text describes the regulatory filing (510(k) Premarket Notification) for a "Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug)". This document is for a medical device (a glove), not an AI/Software as a Medical Device (SaMD) or an algorithm. Therefore, the questions related to AI/algorithm performance metrics (such as MRMC studies, standalone algorithm performance, AI assistance effect size, training set sample size, expert ground truth establishment for AI data) are not applicable to this submission.

The acceptance criteria and device performance for this physical medical device are related to its material properties, physical dimensions, and resistance to chemotherapy drugs, as outlined by various ASTM and ISO standards.

Here's the information extracted and formatted according to the request, with clarification where the questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The reported results for physical and chemical resistance tests seem to be based on representative samples from production, as per the respective ASTM and ISO standards. The specific sample sizes for each test are implicitly defined by these standard test methods (e.g., ASTM D5151 for watertightness mentions testing 125 gloves per batch/size for AQL).
• Data provenance: Not explicitly stated, however, the manufacturer is Inner Mongolia Cureguard Medical Technology Co.,Ltd. (China), suggesting the testing was likely conducted in China or by labs compliant with international standards, possibly in China or elsewhere. The tests are "non-clinical" bench tests, not involving human data or patient populations. The data is retrospective in the sense that it's generated from manufactured product batches for regulatory submission.

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

This question is not applicable as the device is a physical medical glove, and its performance and safety are assessed through objective laboratory tests governed by international standards (ASTM, ISO), not through expert interpretation of medical images or other data that would require a "ground truth" established by experts in a clinical context. The "ground truth" here is the result of standardized material science and chemical permeation testing.

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

Not applicable. This is not a study requiring human adjudication for data interpretation.

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 a physical medical device, not an AI/SaMD.

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

Not applicable. This is a physical medical device, not an AI/SaMD.

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

The ground truth for the device's performance is established by the specified international standard test methods (ASTM and ISO standards) for physical properties, chemical resistance, and biocompatibility. For example, for watertightness, the ground truth is the absence of leaks when tested according to ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time and the specific drug concentration in the testing apparatus according to ASTM D6978. For biocompatibility, it's the observed biological response to testing protocols defined in ISO 10993-5 and ISO 10993-10.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" in the context of an algorithm.

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

Not applicable. See point 8.

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