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The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) are made of natural 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 natural rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) is equivalent to the exiting model, i.e. Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) which had submitted and cleared under 510(k) number K022442.

The difference in this submission is:

• No colour additive is added. a)

The Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less) meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.

The provided document is a 510(k) summary for a medical device, specifically Powder Free Latex Surgical Gloves, Sterile, Coated with Aloe Vera and with Protein Content Labeling Claim (50 micrograms or less).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for the various tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Residual, Protein Level, Biocompatibility).

The provenance of the data is not explicitly stated from a geographical perspective, but the tests were performed by the manufacturer, WRP Asia Pacific Sdn Bhd, located in Malaysia. The nature of the tests (e.g., physical property testing, chemical analysis, biocompatibility animal studies) generally implies that they were conducted specifically for this device (prospective testing) rather than being retrospective analysis of existing data.

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

This type of device (surgical gloves) does not typically involve "experts" in the sense of clinical reviewers establishing ground truth for diagnostic accuracy, as it's a barrier device. The "ground truth" is established by the specified ASTM standards and FDA regulations. The testing involves adherence to these standards, not expert interpretation of clinical data in a test set.

For the biocompatibility tests (Primary Skin Irritation in Rabbits and Dermal Sensitization), these test methods are standardized and typically conducted in specialized laboratories following Good Laboratory Practice (GLP) guidelines. The "experts" in this context would be the toxicologists and laboratory personnel qualified to conduct and interpret these specific animal studies. Their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes where there might be disagreement. This is not applicable to the testing performed for surgical gloves, which involves objective measurements against established engineering and chemical standards.

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

No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or assistive AI devices where human readers interpret medical images or data. Surgical gloves are a barrier protection device, and their effectiveness is evaluated through physical, chemical, and biocompatibility testing, not through human reader performance studies.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device (surgical glove).

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• Established Industry Standards: ASTM D 3577 - 01aE2 (Dimensions, Physical Properties, Freedom from pinholes), ASTM D 6124 - 01 (Powder Residual), ASTM D 5712 – 99 (Protein Level).
• Regulatory Requirements: FDA 21 CFR 800.20 (Freedom from pinholes).
• Standardized Biocompatibility Test Procedures: Primary Skin Irritation in Rabbits and Dermal Sensitization.

This is a form of objective, standardized measurement against pre-defined thresholds rather than clinical outcomes or expert consensus on a diagnostic finding.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As stated above, this device does not involve a training set.

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