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Powder free vinyl patient examination glove 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed.

The document describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" manufactured by Tangshan Luxiong Plastic Products Co.,Ltd. The submission is a 510(k) premarket notification, indicating substantial equivalence to a predicate device.

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 sample size used for the test set for each characteristic. It refers to compliance with standards (ASTM D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, and ISO10099-10), which would imply testing was conducted according to the methodology outlined in these standards.

The data provenance is not specified in terms of country of origin or retrospective/prospective nature. However, since it's a 510(k) submission for a medical device manufacturer in China, the testing was likely performed by the manufacturer, or a contracted lab, to demonstrate compliance with the referenced international/US standards.

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

Not applicable. This submission is for medical gloves, and the evaluation relies on adherence to established material and performance standards, not on expert interpretation of complex data or images for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation is based on objective measurements and compliance with specified standards, not on subjective expert consensus 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 type of study is typically performed for diagnostic or AI-assisted diagnostic devices to assess the impact on human reader performance, which is not relevant for medical gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical glove and does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" for this device is defined by the technical specifications and performance requirements outlined in the referenced standards:

• ASTM standard D 5250-00e4: Specifies requirements for physical properties and dimensions of vinyl patient examination gloves.
• 21 CFR 800.20: Defines the "waterleak test" for freedom from pinholes in medical gloves.
• ASTM standard D6124-01: Specifies methods for determining residual powder on medical gloves.
• Biocompatibility standards (implied by "Passes" for skin irritation and sensitization): These generally refer to ISO 10993 series and involve standardized biological reactivity tests.

8. The Sample Size for the Training Set:

Not applicable. This device is a manufactured product, not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in that context. The "ground truth" for compliance testing is inherently defined by the objective metrics and thresholds within the referenced ASTM, FDA, and ISO standards for the glove's physical and biological properties.

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