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Latex Examination Gloves, Powdered, Blue, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

The provided document describes the acceptance criteria and performance of PT. WRP Buana Multicorpora's Latex Examination Gloves, Powdered, Blue, Non-Sterile.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size used for each "test set" (batch of gloves tested to demonstrate compliance). However, it implies that the tests were conducted on batches of the device to ensure they "Meet" the specified standards.

• Data Provenance: The tests were conducted by PT. WRP Buana Multicorpora, an Indonesian company. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance with existing standards.

3. 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. For device performance testing of physical/chemical characteristics and biocompatibility, specialized laboratory testing and interpretation by appropriately qualified lab personnel are typically involved, but "experts" in the sense of medical professionals adjudicating diagnostic results are not relevant here.

4. Adjudication method for the test set

This information is not applicable/provided as the tests relate to objective physical, chemical, and biological properties of the glove, which are likely evaluated against predefined thresholds in the ASTM standards. There is no mention of a subjective adjudication process by multiple individuals.

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 product (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to its evaluation.

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

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on defined standards set by ASTM (American Society for Testing and Materials) and FDA regulations. For example:

• Physical properties and dimensions: Defined by ASTM D 3578 – 01ae2.
• Freedom from pinholes: Defined by ASTM D 3578 - 01ae2 and FDA 21 CFR 800.20 (specifically, the 1000 ml Water Leak Test).
• Powder amount and Water Soluble Protein Content: Defined by specific ASTM standards (D 6124 - 01 and D 5712 - 99, respectively).
• Biocompatibility: Assessed using standard animal models (Primary Skin Irritation in Rabbits and Dermal Sensitization tests) with established criteria for "passes."

8. The sample size for the training set

Not applicable. This refers to a manufactured product and not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no "training set" for this type of device. The ground truth for evaluating the device's compliance is established by the specified industry and regulatory standards.

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