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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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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.

The provided document is a 510(k) premarket notification for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs). It details the device's technical characteristics, intended use, and performance testing results to demonstrate substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance evaluation for these gloves relates to their physical properties, freedom from holes, powder content, biocompatibility, and most importantly, resistance to permeation by chemotherapy drugs.

Note on Chemotherapy Permeation Acceptance Criteria: The document primarily presents these as reported values and compares them to the predicate device in Table 1 (pages 6-7). The acceptance criteria for these would implicitly be that the breakthrough times are considered sufficient for safe use, or comparable/better than the predicate for equivalent drugs, with a clear warning for drugs with low permeation times. The "Warning: Please do not use with Carmustine (BCNU) and ThioTepa" indicates that the low breakthrough times for these specific drugs are accepted with a cautionary label, rather than requiring an explicit "minimum time" acceptance criterion for regulatory clearance.

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

The document does not explicitly state the total sample size for all tests performed. However, it does provide a specific sample size for one critical test:

• Watertightness Test (ASTM D5151): 125 gloves were tested (indicated by "0/125/Pass").
• For other tests (e.g., physical dimensions, tensile strength, powder content, biocompatibility, chemotherapy permeation), the specific number of gloves or samples tested is not explicitly stated in the provided summary, although the ASTM standards themselves would specify statistical sampling plans.
• Data Provenance: The tests were conducted by the manufacturer, Yunnan Huazhiyuan Medical Technology Co., Ltd. The location is China. The studies are retrospective in the sense that they are conducted on manufactured devices to demonstrate compliance with standards for the 510(k) submission, rather than being part of a prospective clinical trial.

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

This section is not applicable to this type of device and submission. The "ground truth" for the performance of these medical gloves is established through adherence to recognized international and national standards (ASTM, ISO) for physical properties, chemical resistance, and biocompatibility, as measured by laboratory equipment and procedures, not by expert human interpretation or consensus. No human "experts" are interpreting images or clinical data for this non-diagnostic device.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly in imaging or diagnostic device evaluations where multiple readers interpret data and discrepancies need to be resolved. For laboratory bench testing against physical and chemical standards, there is no human interpretation needing adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This section is not applicable. MRMC studies are specific to diagnostic devices, especially those involving image interpretation by multiple human readers, to assess the impact of an AI algorithm on reader performance. This device is a medical glove, a Class I non-diagnostic device, and its performance is evaluated through bench testing against established standards, not human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. This device is not an algorithm or AI-based product. Its performance is entirely standalone in the sense that its physical and chemical properties are measured directly from the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based entirely on laboratory bench testing results measured against predefined acceptance criteria established by recognized international standards (ASTM and ISO).

• Physical properties: Measured dimensions, tensile strength, elongation.
• Freedom from holes: Tested using a water-tightness test.
• Powder content: Measured residual powder.
• Biocompatibility: In vitro cytotoxicity, irritation, and sensitization tests.
• Chemotherapy drug permeation: Measured breakthrough times using specific chemical assays as per ASTM D6978-05.

8. The Sample Size for the Training Set

This section is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for the device's manufacturing process would be based on quality control and manufacturing specifications, not a data training set.

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

This section is not applicable as it pertains to AI/ML devices.

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