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A powdered 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.

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

This document describes the technical characteristics and performance of "Powdered, Natural Color, Latex Examination Gloves, Non-Sterile" produced by Best Putra Gloves Sdn Bhd. It serves as a 510(k) summary for clearance by the FDA.

1. Acceptance Criteria and Reported Device Performance

The device is assessed against ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test. The table below outlines the specific characteristics and their performance:

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test in the "Device Performance" section. However, it indicates that the tests were performed on the device itself. The provenance of the data is not specified in terms of country of origin or whether it's retrospective or prospective. Given the context of a 510(k) submission, these tests would typically be performed prospectively by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The "ground truth" for this device, which refers to ideal design parameters and performance, is established by recognized consensus standards (ASTM D 3578-01a22) and regulatory requirements (FDA 1000 ml Water Leak Test and FDA CFR 800.20 for pinholes), not by expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in clinical studies where expert review is needed for ambiguous cases. In this case, device performance is objectively measured against predefined quantitative and qualitative standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is not relevant for the type of device (examination gloves) or the nature of its evaluation, which focuses on material properties, physical dimensions, and barrier integrity rather than diagnostic interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This information is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply.

7. Type of Ground Truth Used

The ground truth used for evaluating this device's performance is derived from established industry standards and regulatory requirements. Specifically, this includes:

• ASTM standard D 3578-01a22: This standard specifies the requirements for latex examination gloves, covering dimensions, physical properties, and freedom from pinholes.
• FDA 1000 ml Water Leak Test: A regulatory requirement for assessing the integrity and barrier performance of gloves against pinholes.
• FDA CFR 800.20: Regulations pertaining to medical devices, specifically for pinholes in gloves.
• D 6124 - 05: Standard test method for assessing powder on medical gloves.
• D 5712-99: Standard test method for the analysis of protein in natural rubber and its products.
• Biocompatibility tests: These tests (Primary Skin Irritation in Rabbits, Dermal Sensitization) are standard toxicological assessments to ensure the material does not cause adverse biological reactions.

8. Sample Size for the Training Set

This information is not applicable. The concept of a "training set" belongs to machine learning and AI development, which are not relevant to the evaluation of this physical medical device.

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

This information is not applicable, as there is no training set for this type of device evaluation.

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