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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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The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile patient examination gloves. The subject device is blue color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Disposable Nitrile Examination Glove

1. Table of Acceptance Criteria and Reported Device Performance

All reported device performances indicate that the device "Pass"ed the respective acceptance criteria.

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

The document states:

• For Watertightness Test (ASTM D5151): "0/125 leaks" suggests a sample size of 125 gloves were tested for holes.
• For other tests like physical dimensions, thickness, and physical properties (tensile strength, elongation), specific sample sizes are not explicitly stated. However, the standards (ASTM D6319, ASTM D412) typically specify sampling plans.
• Data Provenance: The tests were conducted by the manufacturer, Inner Mongolia Boming Medical Supplies Co., Ltd., which is based in Inner Mongolia, China. The data would therefore be retrospective testing performed on manufactured batches of the device.

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

Not applicable. This device is a disposable nitrile examination glove, and the testing involved evaluating its physical and biocompatibility characteristics against standardized performance metrics rather than interpretative medical imaging or diagnostic results requiring expert consensus.

4. Adjudication method for the test set

Not applicable. As noted above, the evaluation of the device performance against physical and material standards does not involve adjudication by experts. The results are objective measurements or observations (e.g., absence of leaks, tensile strength values).

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 disposable nitrile examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating AI performance in clinical tasks, which is irrelevant here.

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

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

7. The type of ground truth used

The ground truth used for this device's evaluation is defined by established international and national standards for medical gloves:

• ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
• ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) - Implied for physical properties like tensile strength and elongation.
• ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
• ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)

These standards provide the pre-defined, objective criteria (e.g., minimum tensile strength, maximum allowable powder content, AQL for watertightness, non-cytotoxicity, non-irritation, non-sensitization) against which the device's performance is measured.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. This device's performance is evaluated through direct physical and biological testing.

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

Not applicable. There is no training set for this type of device. The "ground truth" (acceptance criteria) for evaluating the finished product's performance is established by the referenced consensus standards (ASTM, ISO).

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