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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).

This document describes the acceptance criteria and performance of the "Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim".

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of image or algorithmic data. Instead, it details various laboratory tests performed on the physical glove product. The sample sizes for each specific test (e.g., dimensions, physical properties, pinholes, protein content, biocompatibility, chemotherapy permeation) are not explicitly stated in the provided summary. However, it is implied that testing was conducted in accordance with the relevant ASTM and ISO standards, which typically prescribe minimum sample sizes for statistical validity.

Data Provenance: The data provenance is from laboratory testing performed by Top Calibre Sdn Bhd (Malaysia) or a contracted lab under their supervision, to demonstrate compliance with international standards (ASTM, ISO). This is retrospective data collected as part of the device's development and regulatory submission process.

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

N/A. This device is a physical product (medical glove), and the evaluation is based on laboratory performance against defined physical and chemical standards, not on expert interpretation of observational data or images. Therefore, clinical ground truth established by experts is not applicable.

4. Adjudication Method for the Test Set

N/A. As the evaluation is based on objective laboratory measurements against predefined standards, there is no need for an adjudication method as would be used in a clinical study with subjective interpretations.

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

N/A. This is a physical product (glove) and not an AI or imaging device, so MRMC studies are not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. This is a physical product and does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by:

• International Standards: Primarily ASTM (American Society for Testing and Materials) standards (D3578-05, D5151-11, D6124-11, D5712-10, D6978-05) and ISO (International Organization for Standardization) standards (10993-10:2010) for physical, chemical, and biocompatibility properties. These standards define the acceptable range or threshold for each characteristic.
• Direct Measurement/Testing: Laboratory measurements and assays were conducted to determine the actual performance values of the gloves (e.g., tensile strength, breakthrough time for chemotherapy drugs). These measurements are then compared directly to the specified acceptance criteria within the standards.

8. Sample Size for the Training Set

N/A. This is a physical product and does not involve AI or machine learning algorithms that would require a training set.

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

N/A. As there is no training set for an algorithm, this question is not applicable.

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

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Patient Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document (K123760) does not specify the sample size used for the test set for any of the performance characteristics. It only states that the device "Meets" the standards or passes the biocompatibility tests.

The data provenance is not explicitly stated as "country of origin" for the specific test data, but the submitter is based in Malaysia. The testing refers to international and US-based standards (ASTM, ISO, CFR), implying these tests were conducted according to those guidelines, potentially by an accredited lab. The study is retrospective in the sense that the test data was collected prior to this submission, but it's not a clinical study involving patients over time.

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

This information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards, not through clinical expert review or diagnosis of medical images/conditions. The "ground truth" for this type of device is defined by the technical specifications outlined in the ASTM, ISO, and CFR standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective assessments, often by human readers (e.g., radiologists interpreting images). The performance of these gloves is assessed objectively against quantifiable standards.

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 results, often with and without AI assistance. This document describes a physical medical device (gloves) and its conformity to technical standards.

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

This information is not applicable. This device is a physical product, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on established industry standards and regulatory criteria. These involve:

• Physical Specifications: ASTM D6319-10 for dimensions and physical properties.
• Freedom from Defects: ASTM D5151-11 and D6319-10 for pin-holes.
• Chemical Properties: ASTM D6124-11 and D6319-10 for powder-free residue.
• Biocompatibility: ISO 10993-10:2010 for dermal sensitization and 16 CFR Part 1500 for primary skin irritation.

These standards define the acceptable range or limits for each characteristic.

8. The Sample Size for the Training Set

This information is not applicable. This submission concerns a physical medical device and its conformity to standards. There is no AI or machine learning "training set" involved in its evaluation.

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

This information is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation, as described in point 7, is established by industry and regulatory bodies through the development and publication of the relevant standards.

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

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.

The provided document describes the acceptance criteria and a study that proves a medical device, specifically "Powder Free Nitrile Examination Gloves," meets those criteria. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for each test. However, it indicates that the tests conform to ASTM standards (D6319, D5151, D6124, F720) and 16CFR Part 1500, which inherently define the sample sizes and methodologies for these tests.

• Data Provenance: The tests are conducted by the manufacturer, IDEAL QUALITY SDN. BHD., located in Malaysia. The type of study (retrospective or prospective) is not explicitly stated, but given the nature of product testing for regulatory clearance, it would be prospective testing conducted by the manufacturer.

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

This document describes the testing of a medical glove, which relies on objective, standardized physical, chemical, and biological tests rather than subjective human interpretation of images or symptoms. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic AI is not applicable here. The "ground truth" is established by the defined test methods themselves and the laboratories performing these tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective and based on established industry standards and regulations. There is no mention of an adjudication process among human readers or experts for the results of these physical and biological tests.

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 relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret cases, and the AI's impact on their performance is measured. For a physical device like an examination glove, this is not applicable.

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

This question is not applicable to the device described. The device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used is based on objective, standardized test methods and criteria defined by:

• ASTM International standards (e.g., D6319, D5151, D6124, F720)
• U.S. Code of Federal Regulations (e.g., 16CFR Part 1500 for skin irritation).

These standards dictate the acceptable limits for various physical properties, freedom from defects, and biocompatibility, which constitute the "ground truth" for the device's performance.

8. The Sample Size for the Training Set

This question is not applicable. The device is a manufacturing product (gloves) 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 type of device.

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

Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Blue

The provided text is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth for a medical device or AI system.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided document. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a description of a performance study.

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