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

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

This document is a 510(k) Summary for Synthetic Vinyl Examination Gloves, a Class I medical device. It details the device's characteristics and its equivalence to a predicate device, supported by non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical Dimensions (ASTM D5250): The sample sizes are implied by the ranges provided for width and thickness (e.g., "XS: 78-79/ Pass" suggests testing across multiple samples within each size). No explicit total sample size or country of origin for the data is provided, but the manufacturer is based in China. The testing is non-clinical.
• Watertightness Test for Detection of Holes (ASTM D5151): 125 leaks were tested from a sample size that is not explicitly stated. The method is "0/125 leaks / Pass", suggesting 125 units were tested (or 125 opportunities for leaks in a larger sample).
• Powder Content (ASTM D6124): "Medium glove is the representative sample of the product." The exact number of medium gloves tested is not specified.
• Physical Properties (ASTM D412): "Medium glove is the representative sample of the product." The exact number of medium gloves tested is not specified.
• Biocompatibility (ISO 10993-5, ISO 10993-10): The studies were conducted on the subject device. No explicit sample size for these biological tests is provided, nor the country of origin of the data.

All data provenance is implied to be from non-clinical laboratory testing performed by or for Yunnan Huazhiyuan Medical Technology Co., Ltd. in China, as indicated by the submitter's information. All studies are retrospective in the sense that they are evaluations of a fully developed product.

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

This document describes non-clinical performance and biocompatibility testing for a medical glove. No human-derived ground truth or expert consensus was used to establish the "ground truth" for the test set. The acceptance criteria are based on established international standards (ASTM and ISO).

4. Adjudication Method for the Test Set

There was no adjudication method as this involved quantitative laboratory testing against pre-defined scientific standards rather than subjective human assessment requiring consensus.

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

No MRMC comparative effectiveness study was done. This is a non-clinical submission for a Class I general hospital device (examination gloves). Such studies are not applicable or required for this type of device.

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

Not Applicable. This device is a physical medical glove, not an algorithm or AI-driven system. The testing is standalone in the sense that the device's performance was evaluated intrinsically against standards, without human intervention affecting its core function during testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on established international standards and specifications:

• ASTM D5250: Standard Specification for Poly (vinyl chloride) 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 basis for physical properties).
• 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. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not Applicable. As no training set was used, no ground truth needed to be established for it.

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The Nitrile 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.

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

The provided document is a 510(k) summary for a Nitrile Patient Examination Glove, which is a Class I device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than complex clinical efficacy studies for novel devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The sample sizes for specific tests are mentioned:

• Watertightness Test (ASTM D5151): The results indicate samples of 125 or 124 gloves were tested (e.g., 0/125, 1/124).
• Powder Content (ASTM D6124): Tests were conducted for each glove size (XS, S, M, L, XL, XXL). The exact number of samples per size is not specified but is implied to be sufficient for a representative measurement.
• Physical Properties (ASTM D412): Tests were conducted for each glove size (XS, S, M, L, XL, XXL) both before and after aging. The exact number of samples per size for these mechanical tests is not specified.
• Biocompatibility (ISO 10993-5, ISO 10993-10): The sample sizes for these in vitro and in vivo (animals, not human) biocompatibility tests are not explicitly stated in this summary.

Data Provenance: The document does not specify the country of origin of the data providers for the non-clinical tests. Since the submitter is based in China, it's highly probable the testing was conducted in China or by accredited labs recognized by the Chinese regulatory system. All tests are non-clinical (laboratory-based) and are retrospective in nature, as they assess characteristics of manufactured products.

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 and submission type. The devices are patient examination gloves, and the tests conducted are adherence to international standards for physical properties and biocompatibility. Ground truth in this context is defined by the objective results of these standardized tests, not by expert consensus or interpretations. There are no human "readers" or diagnostic outcomes being evaluated.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data (e.g., medical images) and their decisions need to be resolved or validated, often against a ground truth. The tests for these gloves are objective measurements following established laboratory procedures.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are typically for diagnostic imaging devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This submission is for a medical glove, which does not involve human interpretation of cases or AI assistance in a diagnostic capacity.

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

This is not applicable. The device is a physical product (a glove), not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Nitrile Patient Examination Glove is established by objective measurements and adherence to recognized international and national standards. Specifically:

• 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.
• ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (implied as referenced for Tensile Strength and Ultimate Elongation).

The ground truth is essentially the quantitative limits and qualitative definitions set forth by these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not involved here. The manufacturer produces the gloves, and samples are selected from production for testing against the established standards.

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

This is not applicable, as there is no training set. The "ground truth" for evaluating the product's performance is derived from the established and published national and international standards mentioned above.

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The Powder Free Vinyl 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.

The subject device is powder free vinyl patient examination gloves. The subject device is colorless. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This document describes the premarket notification for the "Powder Free Vinyl Patient Examination Glove" (K210799). It is a Class I device and the submission focuses on demonstrating substantial equivalence to a predicate device (K163168).

Here's an analysis of the acceptance criteria and study data:

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

The acceptance criteria are implicitly defined by compliance with specific ASTM and ISO standards, and by showing equivalence to the predicate device, particularly regarding physical properties and biocompatibility.

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

The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for tensile strength, pinholes, etc.). It only references compliance with the standards, which typically define sampling plans. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the manufacturer's location in China, it is highly probable that the testing was conducted in China.

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

This information is not applicable. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert human interpretation of medical data (like radiology images).

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in expert-dependent diagnostic studies, not for the physical and biological testing of medical devices like gloves.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools, not for medical gloves. The device is not an AI-assisted tool.

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

A standalone performance study was not applicable/conducted in the context of an algorithm or AI. The performance studies conducted were on the physical and biological properties of the glove itself.

7. The type of ground truth used

The "ground truth" for this device's performance is established by compliance with recognized industry standards and regulatory requirements. This includes:

• Engineering Standards: ASTM D5250 (Standard Specification for Poly (vinyl chloride) 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).
• Biocompatibility Standards: ISO 10993-10 (Tests For Irritation And Skin Sensitization), ISO 10993-5 (Tests For In Vitro Cytotoxicity).
• Predicate Device Equivalence: Demonstrating that the subject device performs similarly or better than a legally marketed predicate device (K163168) in key functional and safety attributes.

8. The sample size for the training set

This information is not applicable. The device is a physical product (medical glove), not an AI algorithm requiring a training set.

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

This information is not applicable. As explained above, there is no AI algorithm or training set for this device.

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