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A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination

The proposed device, Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound fromcontamination. The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015). The classification is: Type I - gloves compounded primarily from natural rubber latex". The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.

This document is a 510(k) Premarket Notification for Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not explicitly stated for each test (length, width, thickness, tensile strength, elongation, stress, pinhole). However, "Average Value of Subject Device" generally indicates testing was done on multiple samples.
• Data provenance:
  • Country of origin: Testing was conducted by Lenora Glove Pvt. Ltd., located in Coimbatore, Tamil Nadu, India.
  • Retrospective or prospective: The document describes "bench tests" performed to verify the device met specifications, which indicates prospective testing of the manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is not an AI/diagnostic device that typically involves expert ground truth establishment in the same way. The "ground truth" for the performance characteristics comes from established international and national standards (e.g., ASTM D3577-09, ASTM D5151-06, ISO 10993-10). These standards define the acceptable range for physical and biological properties of latex surgeon's gloves. Therefore, there were no "experts" in the context of medical image interpretation for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As described above, the acceptance criteria are based on objective measurements against established engineering and medical device standards, not subjective interpretations requiring adjudication.

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 is a physical medical device (surgical glove), not an AI-assisted diagnostic tool or an imaging product. MRMC studies are not relevant here.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is defined by the acceptance criteria established in recognized consensus standards. These standards (e.g., ASTM, ISO) outline specific physical, mechanical, and biological properties that surgical gloves must meet for safety and effectiveness.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. No training set was used for this physical medical device.

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