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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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A Powder Free Nitrile Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.

The Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) will meet all the current specification for ASTM D 6319-00a83

The Perusahaan Getah Asas Sdn. Bhd. Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Dermatitis Potential and Chemotherapy Drug Protection Labeling Claim) demonstrates compliance with established acceptance criteria through a series of tests as detailed in the provided 510(k) submission.

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 for each individual test conducted to demonstrate device performance. However, the data provenance is implied to be from testing conducted by or for Perusahaan Getah Asas Sdn. Bhd., a company located in Malaysia. The studies are all retrospective in the sense that the data is presented post-hoc to demonstrate compliance with pre-defined standards. The data itself would have been generated through prospective experimental testing in a laboratory or clinical setting (e.g., the Modified Draize Test would involve human subjects in a prospective manner).

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

For the most part, the "ground truth" for the performance tests (e.g., dimensions, physical properties, freedom from pin-holes, powder-free residue, chemotherapy drug permeation) is established by standardized laboratory methods and instrumentation, not by human expert consensus in the way a medical image interpretation might be. These are objective measurements against established ASTM and ISO standards.

For Biocompatibility tests (Dermal Sensitization, Primary Skin Irritation, Cytotoxicity, and the Modified Draize Test for Low Dermatitis Potential), experts would have been involved in the design, execution, and interpretation of these studies. However, the exact number and qualifications of these experts (e.g., toxicologists, dermatologists, clinical researchers) are not specified in the provided document. The Modified Draize test, by its nature, would typically involve at least one qualified dermatologist or clinician to assess skin reactions.

4. Adjudication Method for the Test Set:

For the physical and chemical property tests, adjudication is not typically applicable in the same way as for medical image interpretation or clinical trials involving subjective assessment. The results are generally objective measurements against established thresholds according to the given standards.

For the biocompatibility and low dermatitis potential tests, if multiple assessors were involved in evaluating skin reactions in the Modified Draize Test, their findings would likely be subject to an adjudication process to reach a consensus, but the document does not specify any adjudication method. It only states the conclusive finding ("Did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis in human subjects.").

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a patient examination glove, and its performance is evaluated through physical, mechanical, and biological properties, not through human interpretation of cases.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical product (a glove), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" does not apply. The device's performance is inherently "standalone" in the sense that it is measured directly without human-in-the-loop interpretation.

7. Type of Ground Truth Used:

The ground truth for most of the performance criteria (dimensions, physical properties, pin-holes, powder residue) is based on objective measurements against publicly recognized and established industry standards (ASTM, ISO, CFR).

For biocompatibility and low dermatitis potential, the ground truth is established through experimental results from standardized in-vitro and in-vivo tests designed to assess biological responses, with clinical observations (for the Modified Draize Test) serving as the ultimate verification of safety for skin contact.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The manufacturing process and quality control would involve ongoing testing, but this is not analogous to an AI 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.

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