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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 (Powdered and Powder Free) is a sterilized 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, per standard ASTM D3577-0961, the rubber surgical gloves classification is: "Type I - gloves compounded primarily from natural rubber latex". The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided radiation sterilized 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 describes the performance testing for "Annuy Latex Surgeon's Gloves (Powdered and Powder Free)" to demonstrate substantial equivalence to a predicate device (K130301). The study is a non-clinical bench test study.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against various ASTM and ISO standards. The tables below summarize the acceptance criteria (standards) and the reported device performance for both powdered and powder-free gloves.

For Powdered Latex Surgeon's Gloves:

For Powder-free Latex Surgeon's Gloves:

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

• Sample Size: The document does not explicitly state the exact sample size for each test. For example, for "Palm width," it provides a range of measured values (e.g., 76~80 mm for size 6) rather than listing individual measurements or a specific count of gloves tested. However, the tests are stated to comply with referenced ASTM and ISO standards, which typically specify minimum sample sizes for such evaluations.
• Data Provenance: The testing was conducted by Anhui Anyu Latex Products Co., Ltd in China. It is a retrospective study since the data is collected and presented after the manufacturing and testing of the gloves.

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

This document describes non-clinical, bench testing of physical and chemical properties of a medical device (surgical gloves). As such, "ground truth" is established by adherence to recognized international standards (ASTM and ISO). There are no human experts used to establish a clinical ground truth for this type of test.

4. Adjudication Method for the Test Set

Not applicable. The product performance is evaluated against objective, standardized criteria defined by ASTM and ISO specifications, not subjective human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a non-clinical bench test report for physical and chemical properties of gloves, not a clinical study involving human readers or cases.

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

This refers to a medical device, specifically surgical gloves, and not an algorithm or AI. Therefore, this question is not applicable. The performance described here is the inherent physical and chemical properties of the manufactured glove itself, which are measured using various testing methodologies.

7. The Type of Ground Truth Used

The "ground truth" for the test results is established by objective, quantitative measurements against the pre-defined specifications and acceptance criteria outlined in the referenced ASTM and ISO standards (e.g., ASTM D3577-09e1 for dimensions and physical properties, ASTM D5151-11 for freedom from holes, ASTM D6124-11 for powder amount, ASTM D5712-10 for protein content, ISO 10993-10 for biocompatibility, and ISO 11137-1:2006 for sterilization).

8. The Sample Size for the Training Set

Not applicable. This is a report on the testing of a manufactured medical device, not an AI/ML algorithm development. There is no concept of a "training set" in this context.

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

Not applicable. As explained above, this is not an AI/ML algorithm study.

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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 (Powdered and Powder Free) is a sterilized 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. per standard ASTM D3577-0961, the rubber surgical gloves classification is: "Type 1 - gloves compounded primarily from natural rubber latex". The proposed device include Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same colour, creamy white. The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10% and place in a sterility maintenance package to ensure a shelf life of 3 years.

The provided text is a 510(k) summary for Latex Surgeon's Gloves. This document focuses on demonstrating Substantial Equivalence (SE) to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance, especially not in the context of an AI-powered diagnostic or medical imaging device.

Therefore, many of the requested sections related to AI performance, clinical studies, ground truth establishment, expert adjudication, and sample sizes for AI training/testing are not applicable to this type of submission.

However, I can extract the acceptance criteria (which are largely compliance with established ASTM and ISO standards) and the "device performance" as reported through these benchmark tests.

Acceptance Criteria and Device Performance

Study Details (Non-Applicable for AI/Diagnostic Device)

Since this is a submission for a Latex Surgeon's Glove and relies on bench testing against established standards for substantial equivalence, the following sections are not relevant to this type of medical device submission.

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical gloves tested according to ASTM and ISO standards. The document does not specify the number of gloves tested for each standard, nor their country of origin (beyond the manufacturer being in China). The tests are inherently retrospective in nature, as they evaluate manufactured products.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" for glove performance is defined by the objective measurements and pass/fail criteria within the ASTM and ISO standards, not by expert consensus in the diagnostic sense.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is determined by adherence to quantitative and qualitative criteria defined in the standards.
4. 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 not an AI/diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/diagnostic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the device's performance is established by the definitions and pass/fail criteria within the referenced ASTM and ISO consensus standards. For example, "Freedom from Holes" is determined by a specific test method (ASTM D5151) that provides an objective result.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Acceptance:

The submission confirms that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The study essentially involved performing the tests specified by recognized consensus standards:

• ASTM D3577-09e1: Standard Specification for Rubber Surgical Gloves (covers dimensions, physical properties, freedom from holes, powder content, protein content).
• ASTM D5151-06 (Reapproved 2011): Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06 (Reaffirmation 2011): Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D5712-10: Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
• ASTM D6499-07: Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
• ASTM F1929-98 (2004): Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
• ASTM F88/F88M-09: Standard Test Method for Seal Strength of Flexible Barrier Materials.
• ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (biocompatibility).
• ISO11137-2: 2006: Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose.

The conclusion drawn from these bench tests was that the "test results demonstrated that the proposed device complies with the following standards" and therefore is Substantially Equivalent to the predicate device, K063757. The specific numerical results of these tests and the exact sample sizes used for each test are not detailed in this 510(k) summary, but compliance implies that the tested samples met the criteria set forth in these standards.

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