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A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.

The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs." This is a medical device, and the data presented relates to its physical and chemical properties, not an AI/ML powered device. Therefore, many of the requested fields are not applicable.

Here's the information extracted from the document based on the prompt:

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

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 sample size for the tests conducted to determine the breakthrough detection times or other physical properties. It generally refers to conducting tests "in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," and other ASTM and ISO standards. These standards typically specify sample sizes for their respective tests. The provenance of the data is implied to be from the manufacturer's testing (Maxter Glove Manufacturing Sdn Bhd) in Malaysia, as they are the submitter of the 510(k). The tests are prospective in nature, as they are performed to demonstrate compliance with standards for the device being submitted.

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 a physical device (gloves) and the "ground truth" is established through standardized laboratory testing against chemical permeation and physical properties, not through expert consensus on medical images or diagnoses.

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

Not applicable. This is a physical device.

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/ML powered medical device.

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

Not applicable. This is a physical device.

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

The "ground truth" for this device is based on objective measurements conducted according to established international and national standards (e.g., ASTM D6319-10, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993). This involves laboratory measurements for physical dimensions, tensile strength, elongation, freedom from holes, powder residue levels, breakthrough time for chemotherapy drugs, and biocompatibility endpoints (irritation, sensitization, cytotoxicity).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML-powered device that requires a training set.

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

Not applicable. This is a physical device.

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Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue is a disposable device intended for Medical Purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue. A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.
Summary of Technological Characteristics:
Cuff: Beaded
Material: Nitrile
Powder Residue: Maximum 2mg/glove
Quality Assurance: In compliance with ASTM D6319-10, ISO 2859-1, manufactured under ISO9001:2008 and ISO 13485:2003
Physical Properties:
Overall Length: 240 mm minimum
Width: 95 mm minimum (for medium glove)
Thickness: .05 mm minimum
BEFORE AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 500% minimum
AFTER AGING: Tensile Strength: 14.0 Mpa minimum, Ultimate Elongation: 400% minimum
Special Properties: None
Packaging: 150 pcs per dispenser box, 10 boxes per case, 1,500 gloves per case
Sizes: XS — XL

This document describes the acceptance criteria and performance of "Non-Sterile, Powder-Free, Nitrile Examination Gloves Blue" (K112012), not an AI device. Therefore, many of the requested sections related to AI device studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable.

Here's the available information based on the provided text, adapted to the closest relevant categories:

1. Table of Acceptance Criteria and Reported Device Performance

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A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.

The provided documents describe the performance of "Non-sterile, Powder-free Blue Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs" (K101822) against various acceptance criteria relevant to medical examination gloves and specifically for their resistance to chemotherapy drugs.

Here’s a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on established ASTM (American Society for Testing and Materials) standards and a comparison to a legally marketed predicate device (K082957). The key performance indicator for chemotherapy drug resistance is the "Breakthrough Detection Time" as per ASTM D6978-05.

Acceptance Criteria and Reported Device Performance for K101822

Summary of Study Proving Acceptance:

The device K101822 was shown to meet its acceptance criteria through various tests described in the "Substantial Equivalence Discussion" (Document 2, page 2 of 2) and the "CONCLUSION" (Document 4, page 1 of 1). The primary study for chemotherapy drug resistance was conducted according to ASTM D6978-05. For other characteristics like dimensions, physical properties, freedom from pinholes, and powder-free status, the device was tested against and found to meet ASTM D6319-00a-05, ISO 2859-1 (for water leak test), ASTM D5151-06 (for detection of holes), and ASTM D6124-06 respectively. Biocompatibility tests included Primary Skin Irritation in Rabbits and Guinea Pig Maximization tests.

The device's performance was directly compared to a legally marketed predicate device, Siam Sempermed Corp. Ltd.'s Non-sterile, Powder-free Nitrile Examination Glove (K082957), showing substantial equivalence in all tested parameters, except for highlighting the short permeation times for Carmustine (BCNU) and Thiotepa, for which the gloves are explicitly not approved.

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

• Sample Size for Test Set: The specific sample sizes for each test (e.g., number of gloves tested for chemotherapy permeation, number of rabbits/guinea pigs for biocompatibility, or specific counts for physical properties) are not explicitly stated in the provided documents. The documents only state that the device "Meets ASTM D6319-00a-05," "Meets ASTM D6124-06", etc., which implies that the testing was performed according to the methodologies and sample size requirements specified in those respective ASTM/ISO standards.
• Data Provenance: The data is presented as part of a 510(k) Premarket Notification submission to the FDA by SGMP Company Limited, located in Thailand (Document 0, page 1 of 2). This indicates the testing was conducted by or on behalf of the manufacturer, and generally, such data would be generated in a controlled laboratory environment. The documents do not specify the country of origin of the specific lab that conducted these tests, but the manufacturer is based in Thailand. The studies were retrospective in the sense that they were conducted to characterize the finished medical device for regulatory submission, rather than as part of a clinical trial.

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

This question is not applicable to this type of device submission. The "ground truth" for the performance of these examination gloves is established through standardized laboratory tests (e.g., ASTM standards) measuring physical and chemical properties, not through expert human interpretation or clinical ground truth. Therefore, there are no "experts" in the sense of medical professionals establishing ground truth for diagnostic accuracy, nor are their qualifications relevant here.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., for image interpretation) to resolve disagreements among experts. The performance of these gloves is determined by objective, quantitative laboratory measurements according to published standards.

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 question is not applicable. An MRMC study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers evaluate cases with and without AI assistance. This submission describes an examination glove, which is a physical barrier device, and does not involve human readers or AI assistance.

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

This question is not applicable. This describes a physical medical device (examination gloves), not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for performance validation is based on objective, quantitative measurements obtained through standardized laboratory testing protocols, primarily from ASTM standards (D6319-00a-05, D6124-06, D6978-05) and ISO 2859-1. For biocompatibility, the ground truth is established by the observed biological responses in animal models (rabbits and guinea pigs) according to standardized tests for skin irritation and sensitization. The device's performance is then compared against the requirements specified in these standards and against the performance of a legally marketed predicate device.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI model or algorithm that requires a "training set" of data.

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

This question is not applicable as there is no training set for this type of device.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of ASTM-D6319-00aE1 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document describes the "NON-STERILE POWDER FREE BLUE NITRILE EXAMINATION GLOVES WITH VANILLA SCENTING," a patient examination glove. The provided text outlines the device's classification, intended use, and its equivalence to a predicate device, but it lacks detailed information regarding specific performance acceptance criteria and study data typical for AI/ML device evaluations.

Therefore, for aspects related to AI/ML device evaluation, the information is not available in the provided text. The following describes the available information focused on the
glove's conformity to standards.

Acceptance Criteria and Device Performance for Powder-Free Blue Nitrile Examination Gloves with Vanilla Scenting

The acceptance criteria for this device are based on its conformity to recognized industry standards for patient examination gloves. The performance of the device is reported as meeting these standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The provided summary does not detail a specific "test set" in the context of sampling a batch of gloves for evaluation. Instead, the device's performance is stated as meeting the requirements of a recognized standard, ASTM-D6319-00aE1. This standard outlines various tests (e.g., physical properties, barrier integrity) that examination gloves must pass. The glove manufacturer is responsible for ensuring ongoing compliance through their quality system, which would involve sampling and testing according to the standard's guidelines. The document does not specify the country of origin of the data or whether the data is retrospective or prospective, as it implicitly refers to adherence to a standard rather than a specific study.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable. For examination gloves, "ground truth" is established by adherence to specified physical and chemical properties defined in standards like ASTM-D6319-00aE1, rather than through expert consensus on diagnostic images or clinical outcomes. The experts would be professionals in materials testing, quality control, and regulatory compliance who ensure the manufacturing process and product meet the standard's specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjectively assessed data, such as medical image interpretation, to resolve discrepancies among experts. For glove performance, objective measurements against technical specifications dictate acceptance.

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

This information is not applicable. An MRMC study is relevant for evaluating the effectiveness of a diagnostic tool, such as how AI assistance improves human interpretation of medical images. This device is a medical glove, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. This device is a physical medical product, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth used for this device is based on objective measurements against established technical specifications and performance criteria outlined in the ASTM-D6319-00aE1 standard. This includes physical properties (e.g., tensile strength, elongation), dimensions, and barrier integrity (e.g., pinhole detection). It does not involve expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic devices.

8. Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms or AI models. This product is a medical glove, manufactured according to established processes and tested against standards. There is no AI model or training involved in its development as described.

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

This information is not applicable for the same reasons mentioned in point 8.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and the study that proves the device, SMART SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT, meets these 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

For the water-tightness test, the sample size used was 200 pieces for each glove size (Small, Medium, M-Large, Large). This suggests a total of 800 gloves were tested for water tightness.
The data provenance is from the manufacturer's internal testing (Shield Gloves Mfr's), conducted to meet FDA and ASTM standards. The specific country of origin is Malaysia (Shield Gloves Manufacturer (M) Sdn. Bhd.). The data appears to be prospective as it involves direct testing of manufactured batches.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for any of the tests. The tests performed (dimension, physical properties, water leak, biocompatibility, residual powder) are objective measurements against established ASTM and FDA standards, not subjective expert assessments.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests rely on objective measurements and pass/fail criteria against predefined standards (ASTM, FDA). There is no indication of a need for expert adjudication for these specific performance metrics.

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 involving human interpretation of results (e.g., radiology images) to assess the impact of AI on human reader performance. For examination gloves, the performance metrics are largely objective and physical.

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

Yes, the studies described are all standalone performance evaluations of the glove itself. There is no algorithm or human-in-the-loop component relevant to the testing presented. The device is a physical product, not an AI or software-as-a-medical-device.

7. The Type of Ground Truth Used

The ground truth for all evaluated parameters were established standards and specifications:

• ASTM D3578-95 and ASTM DRAFT NITRILE for dimensions, tensile strength, and ultimate elongation.
• FDA specified 1,000 ml water leak test and ASTM D 5151-90 for water tightness.
• FDA biocompatibility requirements for primary dermal irritation and skin sensitization.
• FDA internal requirements (not exceeding 2 mg/glove) for residual powder content, measured by ASTM D 6124.
• Negative Iodine test for cornstarch presence.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical product (nitrile gloves) and not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical medical glove.

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