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The Single-Use Latex Sterile Surgical Gloves are device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Single-Use Latex Sterile Surgical Gloves 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- 09(15), the rubber surgical gloves classification is: Type 1-qloves compounded primarily from nature rubber latex." The qloves are powderfree and available in white in sizes 6, 6.5, 7, 7.5, 8, 8.5 and 9. The proposed device is provided Radiation sterilized to achieve the sterility Assurance Level (SAL) of 10-6. The latex surgical glove shelf life is 3 years.

This document is a 510(k) Pre-market Notification for a medical device, specifically Single-Use Latex Sterile Surgical Gloves (SG100). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive study proving novel effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two tables relevant to acceptance criteria and device performance:

Table 1: Comparison of Technological Characteristics (Proposed vs. Predicate) - This table indirectly shows performance against standards and similarities with the predicate.

Table 2: Characteristics Comparison including Acceptance Criteria and Performance (This table on pages 6-8 directly addresses performance against standards)

2. Sample size used for the test set and the data provenance

The document specifies non-clinical tests were conducted according to various ASTM and ISO standards (pages 9-10). These standards define sample sizes for specific tests (e.g., AQL for holes, specific number of samples for physical properties, etc.). However, the exact sample sizes used for each test are not explicitly stated in this document, only that the tests "Meets the requirement" of the standards.

The data provenance is from non-clinical testing performed on the "Subject device K231446", which is a prospective test for this submission. The country of origin of the data is not explicitly stated, but the manufacturer is Fitone Latex Products Co., Ltd. Guangdong, China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is a physical product (surgical gloves) and the performance criteria are based on objective measurements defined by international standards (ASTM, ISO, USP). Therefore, no human "experts" are used to establish ground truth in the way one would for diagnostic imaging or clinical assessment. The "ground truth" is the established technical specification in the referenced standards.

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

Not applicable. This is for objective physical/chemical testing per standards, not for 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

Not applicable. This device is a surgical glove, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical product, not an algorithm.

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

The ground truth for the performance of the surgical gloves is based on international consensus standards and specifications (ASTM D3577-19 for physical properties, ASTM D5151-19 for holes, ASTM D6124-06 for residual powder, ASTM D5712-15 for protein content, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization, and USP standards for bacterial endotoxin and pyrogenicity). These standards define the acceptable range or threshold for each characteristic.

8. The sample size for the training set

Not applicable. This is a physical product, not an AI model requiring a training set.

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

Not applicable.

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