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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL.

Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05. The gloves are single use, disposable, and provided non-sterile.

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

Acceptance Criteria and Device Performance

The device in question is "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K242533).

Non-Clinical Performance Data

Clinical Performance Data

Study Information

Due to the nature of the device (patient examination gloves) and the provided documentation, several sections of your request are not directly applicable or explicitly detailed. This document is a 510(k) summary for a Class I medical device, which typically relies more on performance testing against established standards and equivalence to predicates rather than complex clinical trials like those for novel therapeutic devices.

Here's what can be extracted from the document:

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

   • Permeation Tests (ASTM D6978-05): The document does not specify the exact sample size used for the permeation tests for each chemical. The standard ASTM D6978-05 typically outlines the number of replicates required (e.g., three specimens).
   • Biocompatibility Tests (ISO 10993 series): Similarly, the sample sizes for these tests are not explicitly stated in the summary but would be specified by the respective ISO standards.
   • Clinical Test (Modified DRAIZE-95 Test): A 305-subject study was completed. The country of origin and whether it was retrospective or prospective is not specified, but such a test is typically prospective to evaluate a new or modified device.
   • Data Provenance: The document generally refers to testing "under the conditions of this study," without specifying the country of origin for non-clinical tests. The manufacturer is based in China.

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

   • For the non-clinical tests (physical properties, chemical permeation, biocompatibility), the "ground truth" is established by the standardized methods themselves (ASTM and ISO standards) and objective measurements by qualified laboratory personnel. The number of "experts" and their specific qualifications beyond standard lab certifications are not typically detailed in these summaries.
   • For the clinical test on dermatitis potential, the "ground truth" is derived from the subjects' reactions as evaluated by the study investigators. The qualifications of these investigators are not provided.

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

   • For the non-clinical tests, adjudication methods like 2+1 or 3+1 are not applicable. Results are based on objective measurements against defined criteria.
   • For the clinical test (Modified DRAIZE-95), the document does not specify an adjudication method. Clinical studies of this nature usually involve clinical investigators observing and documenting reactions, and a statistical analysis of the aggregate results.

4. 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 physical product (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

   • Not applicable. This is a physical device, not an algorithm.

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

   • Physical and Chemical Tests: The ground truth is based on the objective measurements of the glove's properties (dimensions, strength, elongation, watertightness, powder residue) and breakthrough detection times for chemicals, all conducted according to recognized ASTM and ISO standards.
   • Biocompatibility Tests: Ground truth is determined by the biological response observed in in vitro (cytotoxicity) or in vivo (irritation, sensitization, acute systemic toxicity) models as interpreted against the acceptance criteria of the ISO 10993 standards.
   • Dermatitis Potential Clinical Test: The ground truth is the observed clinical reactions of human subjects to the device, evaluated against criteria for allergic contact sensitization.

7. The sample size for the training set:

   • Not applicable. This pertains to an algorithm or machine learning model. This device is a physical product.

8. How the ground truth for the training set was established:

   • Not applicable. As above, this is for an algorithm or machine learning model.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." It is important to note that this is a 510(k) summary for a medical device (gloves), not an AI/algorithm-driven device. Therefore, many of the requested fields related to AI clinical studies, such as sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable.

The studies described are non-clinical performance tests for the gloves themselves, not an AI system.

Here's a breakdown of the requested information based on the provided text:

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

Detailed Chemotherapy Drug Permeation and Fentanyl Citrate Comparison Claim (Subject device K232266 performance):

Warning: Do not use with Carmustine (22.8 minutes) and Thiotepa (46.9 minutes).

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

The document does not specify general "sample sizes" for the test set in terms of medical images or patient data. Instead, it refers to standardized testing methodologies for physical and chemical properties of gloves. For instance, ASTM D5151 for water leak test would involve a certain number of gloves per batch as per AQL (Acceptable Quality Limit) standards, but the specific quantity is not stated in this summary. The data provenance is generally implied to be from laboratory testing conforming to the cited ASTM and ISO standards. The country of origin of the device manufacturer is China. These are prospective tests performed on the manufactured product.

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)

Not applicable. This is not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or patient data. The "ground truth" for the device's performance is established by the specified pass/fail criteria of the ASTM and ISO standards for glove manufacturing and material properties. The tests are laboratory-based and measure physical/chemical attributes.

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

Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic or screening studies, not for the physical and chemical testing of medical 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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for this device is based on standardized test methods and predetermined acceptance criteria defined by international and national standards organizations such as ASTM and ISO. These standards dictate acceptable physical dimensions, mechanical properties, chemical permeation resistance, and biological safety (e.g., irritation, sensitization, systemic toxicity) for medical examination gloves. For instance, for chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time according to ASTM D6978-05(2019).

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no "training set."

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

Not applicable. As this is not an AI device, there is no "training set" or ground truth established in that context.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019).

Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.

The provided text describes the acceptance criteria and study results for "Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)".

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Chemotherapy Drug and Fentanyl Citrate Permeation Performance:

Black Glove:

Green Glove:

Warnings: Do not use with Carmustine and Thiotepa due to extremely low permeation times.

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

The document does not explicitly state the specific sample sizes for each test in the acceptance criteria. However, compliance with ASTM and ISO standards for products like medical gloves typically involves defined sample sizes for testing (e.g., AQL levels for freedom from holes). The data provenance is not specified, but the testing was conducted to international standards (ASTM, ISO). Given this is a 510(k) submission for a physical device (gloves), the testing is prospective, performed on the manufactured product.

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):

Not applicable. This device is a physical product (medical gloves) and its performance is evaluated against engineering and material standards (ASTM, ISO), along with chemical permeation resistance. There is no human interpretative element requiring expert consensus or ground truth in the way medical imaging AI devices do. The "ground truth" here is the result of standardized physical and chemical tests.

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

Not applicable. As this is not an AI/diagnostic device, there is no adjudication process involving human experts to establish ground truth from data.

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 medical device.

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

Not applicable. This is not an AI medical device. The tests performed are standalone in the sense that the device itself is subjected to a test, and its performance is measured directly against predefined criteria without human intervention in the result determination beyond operating the testing equipment.

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

The "ground truth" for this device's performance is established by standardized laboratory testing protocols and predefined limits specified in international standards (ASTM D6319-19, ASTM D6978-05 (2019), ISO 10993 series, etc.). For example, the minimum tensile strength, elongation percentages, AQL for holes, and breakthrough detection times for chemicals are directly measured and compared against the specified numerical criteria from these standards.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no training set for this type of device, this question is not relevant.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate and select other drugs in accordance with ASTM D6978.

Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small. Medium. Large. Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile. The glove has biodegradation property within landfills tested per ASTM D5511.

The acceptance criteria for the Biodegradable Nitrile Powder Free Examination Gloves and their reported performance are detailed in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes for each test mentioned (e.g., number of gloves tested for each specific drug permeation, or for physical properties). However, it references established ASTM and ISO standards for these tests. These standards typically define the sampling plans and statistical requirements for demonstrating compliance. The data provenance is derived from non-clinical laboratory testing (in-vitro studies) performed by the manufacturer or a contracted lab, rather than human test subjects or clinical data. There is no information on the country of origin of the data.

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

This section is not applicable. The device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biological tests (e.g., ASTM D6319, ASTM D6978, ISO 10993 series). The "ground truth" for these tests is established by the well-defined methodologies and acceptance criteria outlined in these international standards, not by expert consensus on clinical findings.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation tasks where human readers' opinions are combined to establish a ground truth. For the non-clinical performance testing of a medical device like examination gloves, the determination of compliance is based on objective measurements against established standard criteria, not on adjudicating expert opinions.

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

This section is not applicable. No MRMC study was conducted as this device is an examination glove, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

This section is not applicable. The device is an examination glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used

The "ground truth" for the performance evaluation of these gloves is based on standardized test methodologies and their defined acceptance criteria. This includes:

• Physical performance standards: ASTM D6319-19 for mechanical properties like length, palm width, thickness, tensile strength, and elongation.
• Leakage detection standards: ASTM D5151-19 for watertight integrity.
• Chemical permeation standards: ASTM D6978-05 (2019) for breakthrough detection time of chemotherapy drugs and other chemicals.
• Biocompatibility standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (skin irritation).

These standards provide objective, measurable criteria for the device's performance.

8. The sample size for the training set

This section is not applicable. The document describes the non-clinical performance testing of a physical medical device (examination gloves), not an AI or machine learning model. Therefore, there is no concept of a "training set" for an algorithm.

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

This section is not applicable, as there is no training set for this device.

Ask a specific question about this device

The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Nitrile Powder Free Examination Gloves, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug and Fentanyl Citrate Permeation (Breakthrough Detection Time - BDT)

Note on Permeation Acceptance: For chemotherapy drugs where the predicate device showed ">240 minutes", the proposed device also achieving ">240 minutes" indicates it meets or exceeds the previous performance. For Carmustine and Thiotepa, while the BDT is lower, the acceptance is ultimately related to the explicit warning not to use them with these drugs, indicating that the observed breakthrough times are treated as insufficient for safe handling.

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

The document does not specify the exact sample sizes used for each individual test against the acceptance criteria (e.g., number of gloves tested for each physical dimension, water leak, or permeation). However, it implies standardized testing according to relevant ASTM and ISO standards. The data provenance is industrial testing, most likely performed in a lab setting, to comply with the specified ASTM and ISO standards.

• Data Provenance: The device manufacturer, Better Care Plastic Technology Co., Ltd. (located in Shenze County, Hebei, China), would have overseen these tests, either internally or through a qualified testing laboratory. The data is thus of industrial origin, specifically from the manufacturer's testing or a third-party lab they used.
• Retrospective/Prospective: These are likely prospective tests conducted specifically for this 510(k) submission to demonstrate compliance with the standards.

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 to this type of device and study. The "ground truth" for examination gloves is established by objective, standardized laboratory tests (e.g., measuring physical dimensions, tensile strength, breakthrough detection time for chemicals, biological reactivity as per ISO standards). It does not involve human expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where expert opinions need to be reconciled. For the physical and chemical testing of gloves, the results are quantitative measurements or direct observations (e.g., pass/fail for a water leak test) and do not require expert adjudication in the same sense.

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

This is not applicable. An MRMC study assesses the performance of human readers (e.g., radiologists, pathologists) in interpreting medical data, often with and without AI assistance, across a range of cases. This device (examination gloves) is a physical product and does not involve human readers or AI assistance in its primary function, nor in the testing performed for its clearance.

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

This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by:

• Standardized Test Methods and Specifications: Specific values and criteria (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough detection time) defined by national and international standards like ASTM D6319-19, ASTM D6978-05, ISO 10993 series.
• Direct Measurement and Observation: The device's physical properties and chemical resistance are directly measured and observed in laboratory settings according to these established protocols.
• Biological Reactivity Endpoints: For biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity), the "ground truth" is determined by established biological endpoints and criteria within the ISO 10993 standards.

8. The sample size for the training set

This is not applicable. This question refers to the training data for an AI algorithm. This device is a physical medical product, and no AI algorithm development is described or relevant to its clearance.

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

This is not applicable for the reasons stated in point 8.

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes = Extra Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

This document describes a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This is a Class I medical device, which means it is subject to general controls and does not require approval of a premarket approval application (PMA). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K192954).

The acceptance criteria and study proving the device meets these criteria are based on non-clinical performance data, as no clinical performance data was provided or required for this device type.

Acceptance Criteria and Device Performance Study

The device's performance was evaluated against various ASTM and ISO standards for medical examination gloves, particularly focusing on their physical properties and resistance to permeation by chemotherapy drugs and Fentanyl Citrate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for water leaks, chemical permeation). However, the tests were conducted according to established industry standards such as ASTM and ISO, which typically define appropriate sample sizes for such evaluations.

The data provenance is based on non-clinical laboratory testing performed by or for Better Care Plastic Technology Co., Ltd. The owner's identification indicates their address as "Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China," suggesting the tests took place in China. The data is retrospective in the sense that it represents completed laboratory tests submitted for the 510(k) application.

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

This information is not explicitly provided in the document. For non-clinical validation of gloves, "ground truth" is typically established by adherence to established test methodologies (ASTM, ISO standards) and the measured physical/chemical properties, rather than expert consensus on subjective evaluations. The "experts" would be the certified laboratories and technicians performing these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. As described above, the validation involves standardized physical and chemical property testing, not subjective human evaluation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices where human readers interpret medical images with and without AI assistance. This document pertains to physical medical devices (examination gloves), for which MRMC studies are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable to a physical medical device like an examination glove. The "performance" being evaluated is the glove's physical and chemicalbarrier properties, not an algorithm's output.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on objective, quantitative measurements obtained through standardized laboratory test methods (e.g., ASTM D6319-19 for physical dimensions, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). These standards define the acceptable range or threshold for a given property.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product (nitrile gloves), 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 a physical device.

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A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's a breakdown of the acceptance criteria and the study information for the Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the individual tests (e.g., tensile strength, pinholes, biocompatibility, resistance to permeation). However, it indicates that the device's physical and performance characteristics meet the requirements of ASTM D 6319-10 and ASTM D 6978-05, which are standards that specify testing methodologies and, implicitly, sample sizes (e.g., AQL levels for pinholes).

The data provenance is from non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The country of origin for the device manufacturer is CHINA (Hebei Province). The testing itself (e.g., ASTM standards, ISO standards) is generally applicable internationally. The document does not specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be considered prospective in the sense that the device was specifically tested to demonstrate compliance for this submission.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM, ISO) that yield quantitative measurements (e.g., tensile strength values, breakthrough detection times, pass/fail for pinholes, irritation/sensitization ratings). There isn't a need for expert consensus in the way there would be for image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the acceptance criteria are based on objective measurements against established standards, not on subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, and the study aims to assess the impact of an AI tool on their performance. For a medical glove, performance is evaluated through physical, chemical, and biological testing as outlined above.

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. Its performance is inherent to the product itself, not an independent algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Standardized Test Results: Compliance with established industry standards such as ASTM D6319-10 (for physical properties like tensile strength, elongation, dimensions, freedom from holes, residual powder) and ISO 10993-10 (for biocompatibility).
• Quantitative Measurement: For chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time (BDT), determined according to ASTM D6978-05.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of the glove and its materials are designed to meet the specifications, and the testing ensures these specifications are met for production batches.

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

This is not applicable for the same reasons as #8.

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