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Powder Free Vinyl Patient Examination Gloves, Colored (White) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.

This 510(k) summary describes the acceptance criteria and study for the Powder Free Vinyl Patient Examination Gloves, Colored (White) marketed by TANGSHAN HENGDA PLASTIC PRODUCTS CO.,LTD.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each test. However, it indicates that the device "meets" the requirements of the specified ASTM standards and 21 CFR 800.20, which would imply that the sample sizes used for those tests were compliant with the respective standards. The data provenance is implied to be from laboratory testing conducted on the manufacturer's gloves to demonstrate compliance with the referenced standards. No specific country of origin for the data is mentioned, but the manufacturer is based in China. The data is retrospective, as it pertains to the evaluation of the finished product.

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

This information is not applicable. The product is a medical device (examination gloves) and the "ground truth" is established by performance metrics defined in regulatory standards (ASTM, FDA CFR) rather than expert interpretation of medical images or data. The "experts" in this context would be the technicians and scientists performing the tests according to the standard protocols. Their specific number and qualifications are not detailed in the summary but are assumed to be appropriate for conducting the tests against the established standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images) where there might be disagreement. For mechanical and biological performance testing of examination gloves, the outcome is determined by adherence to quantifiable metrics within the specified standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging or similar scenarios. As this device is an examination glove, such a study is not applicable.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" in that context is not applicable. The performance described here is the inherent physical and biocompatibility performance of the gloves themselves.

7. Type of Ground Truth Used:

The ground truth used is primarily established through regulatory standards and specifications. This includes:

• ASTM standard D 5250-06: for Dimension and Physical Properties.
• 21 CFR 800.20: for Freedom from pinholes (waterleak test/AQL).
• ASTM standard D 6124-06: for Powder Residual.
• ISO10993-10: for Biocompatibility (Primary Skin Irritation and Dermal sensitization).

These standards define the acceptable performance parameters that the device must meet.

8. Sample Size for the Training Set:

This information is not applicable. Training sets are used for machine learning algorithms. This device is a physical product, not an AI or algorithm, so there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set for this device.

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Powder Free Vinyl Patient Examination Gloves, Colored (White) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (White)".

This product is a medical device (patient examination gloves), which falls under a different regulatory and testing paradigm than AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test/training sets, adjudication methods, MRMC studies, and ground truth for AI) are not applicable.

However, I will provide the information based on the provided text, indicating "Not Applicable" where appropriate for an AI/SaMD context.

Acceptance Criteria and Study for "Powder Free Vinyl Patient Examination Gloves, Colored (White)"

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

• Sample Size: Not explicitly stated as this is a physical product test. The standards (ASTM, CFR) define sampling plans for lot release and quality control, but specific sample sizes for this submission are not provided.
• Data Provenance: The device meets ASTM standards and CFR regulations, implying internal testing by the manufacturer (TANGSHAN ZHONGPU PLASTIC PRODUCTS CO.,LTD. in China) and verified through accredited testing processes. The studies are non-clinical (laboratory/physical testing, biocompatibility studies).

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

• Not Applicable. This is a physical product (gloves) for which "ground truth" in the AI/SaMD sense is not relevant. Performance is determined by objective measurements against established engineering and biocompatibility standards.

4. Adjudication method for the test set

• Not Applicable. Adjudication is not relevant for objective physical and chemical properties testing. Results are typically pass/fail or quantitative measurements against specified limits.

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 not an AI/SaMD device.

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

• Not Applicable. This is not an AI/SaMD device.

7. The type of ground truth used

• Established Standards and Objective Measurements: The "ground truth" for this device's performance is defined by the requirements of recognized standards such as:
  • ASTM standard D 5250-06 (for dimensions, physical properties, powder residual)
  • 21 CFR 800.20 (for freedom from pinholes)
  • ASTM D 6124-06 (for powder residual)
  • ISO 10993-10 (for biocompatibility testing methodology, specifically primary skin irritation and dermal sensitization)

8. The sample size for the training set

• Not Applicable. This is not an AI/SaMD device, so there is no "training set."

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

• Not Applicable. This is not an AI/SaMD device.

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