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A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Glove White Colored Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-00a (Reapproved 2005)

This document is a 510(k) summary for a medical device called "POWDER FREE NITRILE EXAMINATION GLOVE WHITE COLORED." It outlines the device's characteristics, intended use, and its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information, structured around your questions, though it's important to note that many of your specific questions about study design (like sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details) are not applicable to this type of device submission. This is a submission for a Class I medical device (patient examination glove), which typically relies on established performance standards rather than complex clinical studies or AI algorithm evaluations.

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)

• Sample Size: The document does not specify exact sample sizes for each test. For standards like ASTM D 6319-00a, ASTM D 5151-06, etc., the standards themselves define the sampling plans (e.g., AQL levels for pinholes) and test methodologies. Without access to the actual test reports, specific sample sizes cannot be determined from this summary.
• Data Provenance: Not explicitly stated, but the submitter is Central Medicare Sdn. Bhd. located in Malaysia. It is implied that the testing was conducted to meet international and US standards. The biocompatibility tests mention ISO 10993-10:2007 (E) and Consumer Product Safety Commission guidelines, which are international and US standards, respectively.
• Retrospective or Prospective: These tests are laboratory-based performance and biocompatibility assessments, conducted prospectively for the purpose of this submission to demonstrate compliance with standards.

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. For a patient examination glove, "ground truth" as you might define it for an AI or diagnostic device does not apply. Performance is assessed against defined physical, chemical, and biological standards through laboratory testing, not expert interpretation of complex data.

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

• Not Applicable. Adjudication methods are not relevant for the type of objective laboratory tests conducted for this device. The tests have clear pass/fail criteria based on the specified 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

• Not Applicable. This device is a physical medical glove, not an AI or diagnostic imaging system. No MRMC study was performed.

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

• Not Applicable. This device has no algorithmic component.

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

• Objective Standards and Laboratory Results: The "ground truth" for this device's performance is defined by the objective pass/fail criteria established within recognized international and US standards (ASTM D 6319-00a, ASTM D 412-98, ASTM D 5151-06, ASTM D 6124-06, ISO 10993-10, CPSC guidelines) and the reproducible results obtained from laboratory testing against these standards.
• For biocompatibility, the "ground truth" is the absence of dermal sensitization or primary skin irritation based on standardized animal models.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI or machine learning device. The product development process involves design, manufacturing, and testing according to established engineering and quality control principles.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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