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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 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 six sizes: XS, S, M, L, XL, XXL. The subject device is non-sterile.

This document describes the safety and performance of Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) as submitted for FDA 510(k) clearance (K213048). The study focuses exclusively on comprehensive bench testing and biocompatibility assessments, demonstrating the device's adherence to established standards for medical gloves, particularly regarding chemotherapy drug permeation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the specific number of units (gloves) for each test, but it does refer to meeting ASTM standards, which would imply a scientifically sound sampling methodology.
For the Watertightness Test, the results state "0/125/Pass," indicating a sample size of 125 units was tested for holes.
The data provenance is based on non-clinical laboratory testing (bench testing) performed by or for Huayuan Medical Technology (Shangqiu) Co., Ltd. The specific location of testing is not detailed beyond the company's address in Shangqiu City, Henan Province, China. The data would be considered prospective for the purposes of this 510(k) submission, as these tests were conducted to demonstrate compliance for the specific device.

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

Not applicable. This submission relies on objective, standardized bench tests (e.g., ASTM, ISO standards) to establish performance. The "ground truth" is defined by the technical specifications and criteria outlined in these industry-recognized standards, rather than expert consensus on subjective data (like image interpretation in AI/clinical studies). No human experts were used to establish ground truth in the context of clinical/radiological assessment. The experts involved would be laboratory technicians and engineers qualified to perform and interpret the specified physical, chemical, and biological tests according to the standards.

4. Adjudication Method for the Test Set

Not applicable. Since the study involves objective bench testing against pre-defined acceptance criteria from international standards (ASTM, ISO), no human adjudication of test results is typically required beyond standard quality control and verification procedures of the testing laboratory.

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

No. This K213048 submission is for Nitrile Patient Examination Gloves, which are a physical medical device, not a diagnostic imaging AI system. Therefore, an MRMC comparative effectiveness study, which is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, was not performed. The study focuses on the physical and chemical properties of the gloves.

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

Not applicable. This is not an AI-powered diagnostic device or software. The "performance" being assessed is the physical and chemical resistance of the gloves, which is inherently a standalone performance of the material and manufacturing process under controlled laboratory conditions.

7. The Type of Ground Truth Used

The "ground truth" for this device is established by objective laboratory measurements against pre-defined technical specifications and performance criteria set forth in internationally recognized standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ASTM D6978-05, ISO 10993-5, ISO 10993-10). For example, the ground truth for "tensile strength" is a measured force in MPa, which is then compared to an acceptance criterion (e.g., ≥14MPa). For chemotherapy drug permeation, the ground truth is the measured breakthrough time in minutes.

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device (gloves), not an AI/machine learning model. Therefore, there is no "training set." The manufacturing process for physical gloves does not involve machine learning training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a physical device like examination gloves.

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The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is cobalt blue. The subject device is non-sterile.

This document describes the acceptance criteria and the study that proves the device meets those criteria for Nitrile Patient Examination Gloves (K211012).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides specific sample sizes for some tests:

• Watertightness Test (ASTM D5151): 125 samples for each glove size (XS, S, M, L, XL, XXL).
• Data provenance is not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they are testing completed devices against established standards.

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

This information is not applicable as the ground truth for glove testing is established through standardized laboratory procedures and measurements, not expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the testing involves objective measurements against predefined criteria, not subjective interpretations requiring adjudication.

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

A MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices involving human interpretation, not for examination gloves.

6. Standalone Performance (Algorithm Only Without Human-in-the Loop Performance)

This information is not applicable. This device is a physical medical device (examination gloves), not an algorithm or AI system. Its performance is inherent to its physical properties, not a software component.

7. Type of Ground Truth Used

The ground truth used for these tests is based on established industry standards and regulatory requirements, specifically:

• 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) - Inferred from the physical properties testing.
• 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)

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of testing physical medical devices like examination gloves. The manufacturing process is controlled to ensure consistent product characteristics.

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

This information is not applicable for the same reason as point 8.

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The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

This looks like a 510(k) premarket notification for Nitrile Patient Examination Gloves, not an AI/ML medical device. Therefore, the questions about acceptance criteria, study design for AI, sample sizes, expert ground truth, MRMC studies, and standalone performance are not directly applicable.

Instead, the document details the device's adherence to established standards for medical gloves. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document uses a comparison table against a predicate device and adherence to industry standards as its form of "acceptance criteria" and "reported device performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set (for performance and safety): The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for holes, tensile strength, or biocompatibility). However, it references conformity to international standards (ASTM and ISO). These standards typically define sampling plans for lot release and quality control.
• Data Provenance: The tests were conducted by the manufacturer, Huayuan Medical Technology (Shangqiu) Co., Ltd. located in China. The data's origin would therefore be from their internal testing processes. The study is prospective in the sense that the tests were performed on the manufactured device to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for this type of device. "Ground truth" in the context of medical gloves is established by objective measurements against established physical, chemical, and biological standards (ASTM, ISO). There are no human expert interpretations involved in determining if a glove has a hole or its tensile strength.

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

Not applicable. As noted above, the evaluation relies on objective measurement against defined specifications, not subjective interpretation 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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" (or more accurately, the pass/fail criteria) is based on established international and national consensus standards for medical gloves:

• ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
• ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
• ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)

These standards define the acceptable physical properties, barrier integrity, and biocompatibility.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.

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

Not applicable.

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