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The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided document is a 510(k) premarket notification for Vinyl Examination Gloves, a Class I medical device. This type of device does not involve AI or complex software, and thus the request asking about AI/algorithm performance metrics is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing, not through AI/algorithm performance.

Therefore, many of the requested points regarding AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for AI models, cannot be extracted from this document as they are not relevant to the device being described.

However, I can extract the acceptance criteria and performance data for the physical properties of the gloves, as well as the non-clinical testing information:

Description of Acceptance Criteria and Study Proving Device Meets Criteria (for Vinyl Examination Gloves)

This document describes the non-clinical testing performed to demonstrate that the Vinyl Examination Gloves (Yellow) are substantially equivalent to a legally marketed predicate device (K163168). The acceptance criteria are based on recognized standards for medical gloves, primarily ASTM D5250, ASTM D5151, and ASTM D6124, as well as biocompatibility standards ISO 10993-5 and ISO 10993-10.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates sample sizes for specific tests:

• Watertightness Test for Detection of Holes (ASTM D5151): Out of 125 units tested, 0 leaks were detected, meeting the AQL 2.5 requirement.
• Powder Content (ASTM D6124): A "Medium glove" was used as the representative sample.
• Physical properties (ASTM D412): A "Medium glove" was used as the representative sample.
• The exact sample sizes for other physical dimensions and biocompatibility tests are not explicitly stated in the summary, but they are implied to be sufficient to meet the respective standard requirements.

Data Provenance: The tests were conducted by the manufacturer, LIUPING TRADING CO.,LTD., in Shandong, China. The data is from non-clinical testing performed retrospectively for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This product is a physical medical device (gloves), not an AI/algorithm. Ground truth is established through standardized laboratory testing methods, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or AI model output, where there might be disagreements on classifications (e.g., in medical image analysis). For physical product testing, the results are objectively measured against established standards.

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

Not Applicable. MRMC studies are relevant for evaluating the performance of AI-assisted systems in clinical decision-making contexts (e.g., radiology). This is a physical product.

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

The "ground truth" for this device's performance is established by the specifications and test methods defined by recognized industry standards, specifically:

• ASTM D5250 for physical dimensions and properties.
• ASTM D5151 for watertightness (freedom from holes).
• ASTM D6124 for residual powder content.
• ISO 10993-5 for in vitro cytotoxicity.
• ISO 10993-10 for irritation and skin sensitization.

These standards define the objective measurements and pass/fail criteria.

8. The Sample Size for the Training Set

Not Applicable. This is a physical product, not an AI/algorithm that requires a training set.

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

Not Applicable. As stated above, this is a physical product and does not have a "training set" in the context of AI.

Ask a specific question about this device

The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This document is a 510(k) summary for Vinyl Examination Gloves (Yellow). It does not describe an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human reader improvement, standalone performance, ground truth, and training set information is not applicable.

The document assesses the substantial equivalence of the Vinyl Examination Gloves (Yellow) to a predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves (White, Blue, Yellow), K163168).

The comparison focuses on physical dimensions, performance properties, material, and biocompatibility, demonstrating that the new device meets relevant ASTM and ISO standards for vinyl examination gloves.

Ask a specific question about this device