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A patient examination gloves is a disposable device intended for medical purposes worm on the examiner, s hand to prevent contamination between patient and examiner. This gloves is intended for medical and dental use.

Powder Free Latex Exam gloves Blue

This document is a 510(k) Summary for Betelcare Sdn Bhd's Latex Exam Gloves, Blue, Powder Free, Non Sterile. It describes the device's characteristics and how it meets acceptance criteria, primarily through comparison to established ASTM standards.

Here's an analysis of the provided 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 sample sizes used for testing each characteristic. It simply states that the "device meets or exceeds the ASTM Std or Equivalent Standards and FDA pin hole requirements" and provides "Assesment of Non clinical Performance Data" and "Assesment of Biocompatibility."

The data provenance is Malaysia (West Malaysia, specifically Kapar, Selangor Darul Ehsan), as the applicant Betelcare Sdn Bhd is located there and conducts the testing. The data appears to be prospective as it is submitted for premarket notification of a new device.

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 testing relies on adherence to established ASTM standards and FDA requirements, which implies a standardized test procedure rather than expert consensus on individual cases for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this type of device testing. The assessment is based on a device meeting pre-defined quantitative and qualitative standards (ASTM, FDA) rather than human adjudication of performance on a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This document describes the performance of a medical device (exam gloves) against established industry standards. MRMC studies are typically performed for diagnostic or AI-driven systems where human interpretation is a critical component.

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

Yes, in essence. The testing described is a standalone assessment of the physical and biological properties of the examination gloves. There is no "human-in-the-loop" performance in the sense of a diagnostic algorithm assisted by a human. The product's performance (e.g., water leak, tensile strength) is evaluated directly against a standard.

7. The Type of Ground Truth Used

The ground truth used is primarily standardized quantitative measurements against established industry specifications (ASTM D 5151-06, ASTM D 6124-06, ASTM D 3578-05, ASTM D 5712-05e1) and regulatory requirements (FDA pin hole requirements, biocompatibility tests). These standards define acceptable levels of performance.

8. The Sample Size for the Training Set

This information is not applicable or provided. This is a medical device approval summary, not a machine learning model. There is no "training set" in the context of developing examination gloves. The manufacturer would have internal R&D and quality control processes to ensure the product consistently meets specifications, but these are not referred to as "training sets."

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

This information is not applicable for the reasons stated above.

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