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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, per ASTM D6978-05 Standard Practice for Assessment of Resistance 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 qloves 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 acceptance criteria and performance of a medical device, specifically "Disposable Nitrile Medical Examination Gloves (Tested for Use with Chemotherapy Drugs)" (K212834). However, it is not an AI/ML medical device, but rather a physical product.

Therefore, many of the requested criteria for an AI/ML study (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details, etc.) are not applicable to this document. The document details bench testing and biocompatibility assessments, which are standard for physical medical gloves.

Below is a table summarizing the acceptance criteria and reported device performance based on the provided document, along with a clarification of why other requested information is not present for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Clarification regarding AI/ML specific questions:

The provided document is a 510(k) summary for a physical medical device (examination gloves), not an Artificial Intelligence/Machine Learning (AI/ML) based medical device. Therefore, the following requested information is not applicable to this submission:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for physical product testing. Performance testing is done via bench methods on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (e.g., tensile strength, hole detection) is established through standardized laboratory test methods, not expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Testing involves measurable physical properties.
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 device, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on standardized test methods and measurements (bench testing) per ASTM and ISO standards, not medical imagery or pathology.
8. The sample size for the training set: Not applicable. The device does not involve machine learning and therefore has no "training set."
9. How the ground truth for the training set was established: Not applicable.

In summary, the document details the safety and performance evaluation of a medical glove against established national and international standards for physical properties and biocompatibility. It successfully demonstrated substantial equivalence to a predicate device through these non-clinical tests.

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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 document is a 510(k) summary for a medical device: "Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)". It details the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based on your requested format:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• ASTM D6319 (Physical Dimensions, Tensile Strength, Ultimate Elongation): Data is reported for "Lot 1", "Lot 2", and "Lot 3". Each lot appears to represent multiple measurements across different sizes (XS, S, M, L, XL). The exact sample size per lot or per measurement (e.g., how many gloves were measured for length, width, thickness, or subjected to tensile tests) is not explicitly stated, but it follows the standard ASTM D6319 requirements for quality assurance.
• ASTM D5151 (Watertightness): The sample sizes are explicitly stated as 125 gloves per size: XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks, L: 0/125 leaks, XL: 0/125 leaks.
• ASTM D6124 (Powder Content): The sample size for powder content is not explicitly stated.
• ASTM D6978 (Chemotherapy Drug Permeation): The sample size for each drug test is not explicitly stated in the provided text.
• ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation, Sensitization): The sample sizes used for these biocompatibility tests are not explicitly stated, but the tests were conducted "under conditions of the study" which implies adherence to the standard's methodology.
• Data Provenance: All testing appears to be non-clinical (bench testing and laboratory biocompatibility tests). There is no information provided about patient data or country of origin for such data, as this is a device for which clinical testing was not deemed necessary. The testing was conducted in support of a device manufactured by Jiangsu Cureguard Glove Co., Ltd. in China.

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

Not applicable. The "ground truth" in this context is established by standardized physical, chemical, and biological testing methods (ASTM and ISO standards), not by individual expert consensus or interpretation of medical images. The results are objective measurements.

4. Adjudication method for the test set

Not applicable. The tests are based on objective measurements against predefined acceptance criteria from international standards. There is no element of subjective assessment requiring adjudication in the context of these non-clinical tests.

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 medical examination glove, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.

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 and does not involve any algorithm or AI component.

7. The type of ground truth used

The ground truth used for performance validation is based on standardized test methods and their defined performance criteria. Specifically:

• ASTM Standards: ASTM D6319 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ASTM D6978 (chemotherapy drug permeation). These standards define the procedures for measurement and the expected acceptable ranges or thresholds.
• ISO Standards (Biocompatibility): ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These standards define the methods and parameters for assessing the biological safety of the device.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a "training set."

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

Not applicable, as there is no training set for this device.

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The Disposable Nitrile Medical 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.

Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Gloves (K210691)

The provided document describes the acceptance criteria and performance data for the Disposable Nitrile Medical Examination Glove (K210691) in comparison to the predicate device (K171422). The study primarily focuses on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The sample size for the test set is not explicitly stated as a single number but is indicated by the "3 Lots" tested for physical properties, watertightness, and powder content. For the watertightness test (ASTM D5151), a sample size of 125 gloves per lot was tested. The data provenance is China, as the manufacturer, Jiangsu Cureguard Glove Co., Ltd., is located in China. The testing appears to be prospective as it was conducted to demonstrate compliance with standards for a new device submission.

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

This type of device (medical examination glove) does not typically involve human expert interpretation or ground truth establishment in the same way an AI diagnostic tool would. The ground truth for this device is based on objective, quantitative measurements and standardized laboratory test procedures derived from established ASTM and ISO standards. Therefore, the concept of "experts" establishing ground truth for individual cases is not directly applicable here. The "experts" would be the scientists and technicians performing the standardized tests in a laboratory setting, adhering to the specified methodologies.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the testing conducted for this medical device involves objective measurements and standardized laboratory methods, not subjective interpretation requiring adjudication among human readers.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's assistance is evaluated. For medical examination gloves, the performance evaluation is based on physicochemical and biological properties against established standards.

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

This question is not applicable to the device under review. The device is a physical medical glove, not an algorithm or software. The performance evaluation is inherently "standalone" in the sense that the glove's properties are measured directly, without human interpretation in a diagnostic loop.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is objective laboratory measurements and compliance with established international standards (ASTM and ISO). This includes:

• Physical dimensions (length, width, thickness) measured against specified ranges.
• Mechanical properties (tensile strength, ultimate elongation) measured against minimum requirements.
• Barrier integrity (freedom from holes) measured against AQL (Acceptable Quality Level).
• Chemical properties (powder content) measured against a maximum limit.
• Biocompatibility (cytotoxicity, irritation, sensitization) evaluated through in vitro and in vivo (though described as "in vitro" for cytotoxicity, the irritation and sensitization tests typically involve animal or human models as per ISO 10993-10, even if the results are presented as "non-irritant" or "non-sensitizing" without detailing the specific model here) tests against pass/fail criteria.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this device.

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The Disposable Nitrile Medical 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.

This document describes the premarket notification for the "Disposable Nitrile Medical Examination Glove". The acceptance criteria and the study proving the device meets these criteria are detailed through a series of tables and text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• ASTM D5151 (Watertightness): For sizes XS, S, and M, 125 gloves were tested for each size (e.g., XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks). The sample sizes for L and XL are not explicitly stated, but the test methodology implies a standardized approach across sizes.
• Other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility): Specific sample sizes for these tests are not explicitly provided in the document.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective, beyond stating that non-clinical tests were conducted to verify the device met all design specifications.

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

Not applicable. The tests conducted are non-clinical, laboratory-based tests evaluating the physical and biological properties of the medical examination glove against recognized international and national standards (e.g., ASTM, ISO). Ground truth, in the context of expert consensus, is not relevant for these types of tests.

4. Adjudication method for the test set

Not applicable. The tests are standardized laboratory procedures with objective measurements against predefined acceptance criteria. There is no mention of expert adjudication for interpreting results.

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 submission for a medical examination glove, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers.

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 algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation of the Disposable Nitrile Medical Examination Glove is based on widely accepted, published national and international standards for medical gloves. Specifically:

• Physical properties (dimensions, tensile strength, elongation): ASTM D6319 and ASTM D412.
• Freedom from holes: ASTM D5151.
• Powder content: ASTM D6124.
• Biocompatibility (Irritation, Sensitization, Cytotoxicity): ISO 10993-10 and ISO 10993-5.

These standards define the objective and measurable criteria that the device must meet.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set".

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

Not applicable (as it's not an AI/ML device, there is no training set).

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The Disposable Nitrile Medical 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 white. The subject device is non-sterile.

The provided document is a 510(k) summary for a Disposable Nitrile Medical Examination Glove. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. This document is not for an AI/ML medical device, but rather for a physical examination glove. Therefore, many of the requested criteria regarding AI/ML device acceptance, such as expert consensus, MRMC studies, training/test sets, and ground truth establishment, are not applicable to this submission.

However, I can extract and present the acceptance criteria and test results related to the physical and biocompatibility performance of the glove, as described in the document.

Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Glove (K210684)

The device, a "Disposable Nitrile Medical Examination Glove," is classified as Class I and its performance is evaluated against established ASTM and ISO standards for medical gloves, rather than complex AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Non-Applicable Criteria for this Device:

The following requested information is primarily relevant to AI/ML (Artificial Intelligence/Machine Learning) medical devices, which typically involve algorithms processing data (e.g., images, signals) to make predictions or assist in diagnoses. The submitted device, a medical examination glove, is a physical product and its testing is based on established performance standards for materials and manufacturing. Therefore, these items are not applicable to this 510(k) submission:

2. Sample size used for the test set and the data provenance: Not applicable. Tests are standard physical and chemical property evaluations on manufactured gloves, not a data-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is defined by physical/chemical standards, not expert medical opinion on a data set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. No AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on established international standards (ASTM, ISO) for physical properties and biocompatibility of medical gloves.
8. The sample size for the training set: Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary of Study (Non-Clinical Testing):

The study described is a series of non-clinical tests conducted to verify that the Disposable Nitrile Medical Examination Glove meets design specifications and complies with relevant international standards. The tests cover:

• Physical Dimensions: Length, width, and thickness for various glove sizes.
• Physical Properties: Tensile strength and ultimate elongation, both before and after accelerated aging, to assess durability and flexibility.
• Freedom from Holes: Watertightness testing to ensure barrier integrity.
• Powder Content: To confirm it is "powder free" as claimed.
• Biocompatibility: Tests for irritation, sensitization, and cytotoxicity to ensure the material is safe for contact with human skin.

The document reports that all tests demonstrated the proposed device complies with the specified standards and meets the acceptance criteria, leading to the conclusion that it is as safe and effective as the legally marketed predicate device.

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