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The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera meets all the requirements of ASTM standard D 3577 - 01a22 and FDA 21 CFR 800.20.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Powder Free Neoprene Surgical Glove, Sterile, Turquoise Colour and coated with Aloe Vera (Trade Names: Aloetouch, Multiple or Customer's Trade Name)

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 specific sample sizes for each test in the acceptance criteria. It refers to standards like ASTM D 3577 - 01aE2, ASTM D 6124 - 01, and FDA 21 CFR 800.20, which would dictate the sample sizes required for those tests. The data provenance is not specified beyond the fact that the applicant (WRP Asia Pacific Sdn Bhd) is located in Malaysia. The nature of the tests (e.g., physical properties, biocompatibility) suggests these would be laboratory-based, controlled studies, implying a prospective collection for these specific performance tests.

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

This information is not provided. The "ground truth" for these types of device performance characteristics is typically established by adherence to recognized international (e.g., ASTM) and national (e.g., FDA) standards, rather than direct expert consensus on individual test results. The device either "Meets" or "Passes" the quantitative and qualitative requirements set forth by these standards.

4. Adjudication Method for the Test Set

No explicit adjudication method is mentioned. Given the nature of objective performance tests against standards, adjudication in the traditional sense (e.g., 2+1, 3+1 for clinical endpoints) is not applicable. The device's performance is measured against predefined numerical and qualitative thresholds within the specified standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. Surgical gloves are physical barriers, and their effectiveness is assessed through physical and biological testing, not through human interpretation of cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this concept is not applicable to a surgical glove. The device itself is a physical product, not an algorithm, and does not require human-in-the-loop performance in its assessment. Its performance is assessed inherently as a standalone physical device.

7. The Type of Ground Truth Used

The ground truth used is primarily based on established industry standards and regulatory requirements. Specifically:

• ASTM (American Society for Testing and Materials) standards (D 3577 - 01aE2, D 6124 - 01)
• FDA regulations (21 CFR 800.20)
• Standard biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization), which have established pass/fail criteria.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a physical product, not an AI or machine learning model. Therefore, there is no training set as understood in the context of AI/ML development. The "training" for such a device involves manufacturing processes and quality control that ensure consistency with the established standards.

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

As there is no training set for this type of device, this question is not applicable. The manufacturing process is designed to produce gloves that inherently meet the referenced standards, which serve as the "ground truth" for product quality and performance throughout manufacturing.

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