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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, JR Medic Latex Surgeon's Gloves Sterile 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 from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves. 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 using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

The provided document describes the acceptance criteria and a study proving that JR MEDIC Latex Surgeon's Gloves Sterile Powder Free meet these criteria.

Here's the breakdown of the information requested:

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)

The document does not explicitly state the sample size for each specific test within the non-clinical performance data. It indicates "Average value of subject device" for each criterion, implying that multiple units were tested. The data provenance is from JR Engineering & Medical Technologies (M) SDN.BHD., which is located in Malaysia. The study is a non-clinical bench test study to verify that the device meets design specifications, and therefore, the terms retrospective or prospective don't directly apply in the same way they would for a clinical study with human subjects.

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 section is not applicable as the study is a non-clinical bench test for physical and chemical properties of gloves. "Experts" in this context would likely be laboratory technicians or engineers performing standardized tests, rather than medical experts establishing a ground truth for diagnostic purposes. The ground truth is established by the specifications in recognized standards like ASTM and ISO.

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

This is not applicable as the tests are objective measurements against established standards, not subjective assessments 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

This is not applicable. The device is a surgical glove, not an AI-assisted diagnostic tool.

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

This is not applicable for a surgical glove.

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

The ground truth used for the acceptance criteria is based on recognized international standards and specifications for medical devices, specifically:

• ASTM D3577-09(15): Standard Specification for Rubber Surgical Gloves.
• ASTM D 5151-06 (2015): Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06 (2017): Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D5712-15: Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
• ASTM D6499-18: Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
• ASTM F 1929-2015: Standard Test Method for Detecting Seal Leaks in Porous Packaging by Dye Penetration.
• ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
• ISO 10993-11:2017(E) Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity and Biological Tests.
• USP 41 <151> Pyrogen Test.
• ISO 11137-1-2006/ (R) 2010 - validation of sterilization process.
• ISO 11137-2:2013, sterilization of health care products - radiation - part 2: establishing the sterilization dose.

8. The sample size for the training set

This is not applicable as this is a non-clinical bench test for a physical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the reasons stated above.

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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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