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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 1 Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a and FDA Water leak test.

The provided document describes the acceptance criteria and a study for "Non-Sterile Powder Free, Blue Color Nitrile Examination Gloves" manufactured by GREEN PROSPECT SDN. BHD.

Here's the 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 explicitly state the specific sample size used for each individual test (e.g., how many gloves were tested for watertightness or physical properties). However, the performance data is based on "ASTM D6319-00a2 and FDA 1000ML watertight test." ASTM standards typically specify sampling plans. For instance, for watertightness, it specifies an "AQL = 2.5" (Acceptable Quality Limit), which is part of a sampling plan, but not the exact number of units tested.

The data provenance is from Malaysia (Green Prospect Sdn Bhd is located in Perak Darul Ridzuan, Malaysia) and appears to be retrospective in nature, as it's a summary of performance data already collected.

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

This information is not provided in the document. The "ground truth" for these tests are the objective measurement standards established by ASTM D6319-00a and FDA regulations, not expert consensus on individual cases.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements against established standards (ASTM and FDA specifications), not subjective assessment 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 devices involving human interpretation of data, which is not the case for examination gloves.

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

No, a standalone "algorithm only" performance study was not done. This device is a physical product (examination gloves), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective measurement against established industry standards and regulatory requirements. Specifically:

• ASTM D6319-00a: Standard Specification for Nitrile Examination Gloves for Medical Application.
• FDA 1000ML watertight test: A specific regulatory requirement for watertightness.
• FDA Requirements for powder content.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical product evaluated against standards, not a machine learning model requiring 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.

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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 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water leak test.

Here's a breakdown of the acceptance criteria and study information for the Green Prospect Sdn Bhd Non-Sterile Powder Free, Latex Examination Gloves:

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 test. However, it references ASTM D3578-01, which is a standard specification for rubber examination gloves. This standard outlines procedures for sampling and testing. For example, for watertightness, it specifies an Acceptance Quality Limit (AQL) of 2.5, which implies a sampling plan where a certain number of gloves are tested from a lot, and the number of failures must not exceed a specified threshold for the lot to be accepted.

The data provenance is from Green Prospect Sdn Bhd, Malaysia. The studies appear to be retrospective in the sense that the data presented are the results of tests already conducted to demonstrate compliance with existing standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable in this context. The "ground truth" for medical gloves is established by predefined ANSI/ASTM and FDA standards and requirements, not through expert consensus on qualitative assessments. The tests are objective measurements against these established quantitative limits.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed on medical gloves are objective and quantitative measurements (e.g., length, thickness, tensile strength, protein content). The results are compared directly to the numerical acceptance criteria defined in the relevant standards (ASTM D3578-01 and FDA requirements). There is no subjective interpretation requiring an adjudication process.

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

This is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance, comparing human reader performance. This device is a medical glove, and its performance is assessed through physical and chemical property testing, not through human interpretation of cases.

6. Standalone (Algorithm Only) Performance

This is not applicable. This device is a physical product (medical glove), not an algorithm or software. Its performance is inherent in its physical and chemical properties, measured directly through laboratory testing.

7. Type of Ground Truth Used

The ground truth used for evaluating the device is based on pre-established industry standards and regulatory requirements:

• ASTM D3578-01 Standard Specification for Rubber Examination Gloves
• FDA Pinhole Requirements
• FDA Minimum Powder Residual Content
• Label Claim of maximum 50 micrograms per gram of glove or less for water extractable protein.
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test).

8. Sample Size for the Training Set

This is not applicable. This device is a manufactured product (medical glove), not an AI/ML model or a diagnostic algorithm that requires a "training set" in the context of machine learning. The testing described is for product quality control and regulatory compliance.

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

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

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