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

This document describes the process for obtaining 510(k) clearance for the WRP Asia Pacific Sdn Bhd "Powder Free Green Neoprene Surgical Glove, Sterile with Aloe Vera". The clearance is based on the device meeting established performance standards and being substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the "study" that proves the device meets them:

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 used for each individual performance test (e.g., how many gloves were tested for pinholes, or how many rabbits were used for biocompatibility testing). However, it implies that the testing was conducted according to the methodologies outlined in the referenced ASTM standards and FDA regulations, which would inherently dictate minimum sample sizes for statistical validity.

• Provenance: All testing appears to be internal to the manufacturer (WRP Asia Pacific Sdn Bhd) or conducted by third-party labs on behalf of the manufacturer, to demonstrate compliance with international and US standards. The country of origin for the data (and manufacturing) is Malaysia.
• Retrospective or Prospective: The testing would be considered prospective as it was conducted specifically to demonstrate compliance for this device prior to its submission for market clearance.

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

This information is not provided because the "ground truth" for the device's performance is not based on expert consensus of medical images or clinical outcomes, but rather on objective, measurable physical and chemical properties of the glove. The "experts" in this context would be the technicians and scientists performing the ASTM and FDA-mandated tests, adhering to established laboratory protocols.

For example:

• For Dimensions and Physical Properties, the 'ground truth' is the quantitative measurements taken and compared against the numerical limits specified in ASTM D 3577. The experts are the lab technicians and engineers performing these measurements.
• For Freedom from pinholes, the 'ground truth' is the absence of leaks when tested according to ASTM D 3577 (water leak test) and FDA 21 CFR 800.20 (Acceptable Quality Level for defects). The experts are the quality control personnel and lab technicians conducting these tests.
• For Powder-Free, the 'ground truth' is the measured powder residue, which must be less than 2 mg/glove as per ASTM D 6124. The experts are lab technicians performing gravimetric analysis.
• For Biocompatibility, the 'ground truth' is the observed biological response in animal models (rabbits) or in vitro tests. The experts are trained toxicologists and lab personnel specializing in biocompatibility assessments.

4. Adjudication Method for the Test Set:

Not applicable in the human-centric sense (e.g., 2+1, 3+1 for medical image interpretation). The "adjudication" is inherent in the standardized test methods themselves. The results meet or fail the specified criteria. Any discrepancies would involve retesting or investigation into the testing methodology, but not a consensus process among human evaluators in the same way clinical data is adjudicated.

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

Not applicable. This is a medical device (surgical glove), not an AI/software device that assists human readers in interpreting medical data. Therefore, there is no concept of "human readers improve with AI vs without AI assistance."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This is a physical medical device (surgical glove), not an algorithm or AI system. The performance is assessed directly on the product's physical and chemical attributes, not on an algorithm's output.

7. Type of Ground Truth Used:

The ground truth used is primarily objective, measurable physical and chemical properties defined by recognized industry standards (ASTM) and regulatory requirements (FDA 21 CFR 800.20), and biocompatibility testing outcomes in animal models.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of AI or algorithm development. The manufacturing process is refined through quality control and process validation, but this is distinct from an AI training set.

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

Not applicable, as no training set (for AI/ML) is involved. The "ground truth" for ensuring consistent product quality in manufacturing is established through adherence to Good Manufacturing Practices (GMP) and ongoing quality control checks, which verify that the manufactured gloves meet the specified standards.

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