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The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The 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 patient and examiner.

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meats ASTM Standard D 3578-99 requirement for all properties with the exception of ultimate elongation.

Here's a breakdown of the acceptance criteria and study information for the DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

   • The document does not explicitly state the exact sample size for each test. However, it references a "Device Test Report of Compliance" (Attachment 8, not provided) which presumably contains this level of detail.
   • Data Provenance: The tests were conducted by WRP Specialty Products Sdn Bhd, which is based in Malaysia. The data is retrospective in the sense that it was generated for the 510(k) submission, not as a continuous monitoring process.

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

   • This information is not provided in the document. The "ground truth" for glove performance tests like these is typically established by adhering to standardized testing methods (e.g., ASTM D 3578-99 and FDA 1000ml watertight test) rather than expert consensus on individual cases. The expertise lies in the certified labs and personnel conducting the tests according to these standards.

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

   • This concept of "adjudication method" is typically relevant for studies involving human interpretation or subjective assessments. For objective performance tests of physical properties of gloves, there isn't an adjudication process among experts. The results are quantitative measurements against an established standard.

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, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for a medical device like examination gloves, which do not involve reading or interpretation by human "readers" or AI assistance.

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

   • No, a standalone algorithm performance study was not done. This is also inapplicable to an examination glove.

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

   • The ground truth is based on standardized specifications and objective measurements as defined by:
     • ASTM D 3578-99 Standard Specification for Rubber Examination Gloves.
     • FDA 1000 ml watertight test.
   • These standards specify the acceptable ranges and minimums for physical properties like dimensions, strength, and integrity (watertightness).

7. The sample size for the training set:

   • This document describes testing of the final product, not the development of a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of a physical product doesn't involve training data in that sense.

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

   • As there is no training set mentioned or implied for this physical product, this question is not applicable.

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