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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 patients' body, fluids, -.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00 and FDA Water Leak Test.

The provided document describes the acceptance criteria and study for "Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White)".

Description of the Device and Intended Use:
The device is a Class 1 Nitrile Patient Examination Glove, powder-free, intended to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.

Acceptance Criteria and Reported Device Performance:

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes for each test mentioned in the table. It refers to "GI AQL=2.5%" for the watertight test, which indicates a sampling plan based on Acceptance Quality Limit, but not the specific number of gloves tested.
   • Data Provenance: The studies were conducted by SEAL POLYMER INDUSTRIES SDN. BHD. in Malaysia. The nature of the tests (physical property measurements, watertight tests, biocompatibility) implies prospective testing on manufactured gloves.

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

   • This is not applicable as the studies are technical performance tests against established standards (ASTM D6319-00, FDA requirements) and not diagnostic or interpretive tasks requiring expert ground truth establishment.

3. Adjudication method for the test set:

   • Not applicable for these types of performance tests. The results are objective measurements against defined minimums or ranges.

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:

   • No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is not relevant for the performance evaluation of examination gloves, which are physical medical devices.

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

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

6. The type of ground truth used:

   • The "ground truth" for the performance tests consists of established industry standards and regulatory requirements:
     • ASTM D6319-00 Standard for Nitrile Patient Examination Gloves.
     • FDA 1000 ml watertight test requirements.
     • FDA minimum powder residual content requirements.
   • For the biocompatibility tests, the ground truth is "Pass" based on established biological safety evaluation methods (Primary Dermal Irritation Test and Guinea Pig Sensitization test).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

   • Not applicable, as there is no training set for this device.

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