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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, Colored (White) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a premarket notification for a medical device (Powder Free Vinyl Patient Examination Gloves, Colored (White)) and focuses on demonstrating substantial equivalence to a predicate device. It primarily relies on non-clinical testing to meet the acceptance criteria.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Size: Not explicitly stated for specific tests. The document indicates that the device "meets requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." These standards inherently require specific sample sizes for their respective tests, but the exact numbers used in this specific submission are not detailed.
   • Data Provenance: The manufacturing company is based in China: Hebei Handform Plastic Products Co.,Ltd., Julu County industrial park, Xingtai, Hebei Province, 055250, CHINA. It can be inferred that the testing was conducted to demonstrate compliance with these international standards, but the specific location of the testing laboratories is not specified. The study is prospective in the sense that these tests were conducted to demonstrate the device's properties before market entry for regulatory approval.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This question is not applicable to this type of device and study. The "ground truth" for glove performance is established by objective measurements and adherence to recognized standards (ASTM, CFR, ISO) rather than expert consensus on subjective interpretations like in imaging studies.

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

   • This question is not applicable to this type of device and study. Adjudication methods are typically used in clinical trials involving subjective endpoints or complex interpretations, not for objective material property testing.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of data, often with AI assistance. This device is a patient examination glove, so such a study would not be applicable.

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

   • No, a standalone algorithm performance study was not done. This device does not involve an algorithm. The "performance" here refers to the physical and biocompatibility characteristics of the glove itself.

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

   • The "ground truth" for this device is based on objective measurements against established international and regulatory standards for material properties, dimensions, physical characteristics, freedom from defects, powder residue, and biocompatibility. These standards are themselves the "truth" against which the device's performance is measured.
     • 21 CFR 800.20: Freedom from pinholes (water leak test)
     • ASTM D 5250-06: Dimensions, Physical Properties
     • ASTM D6124-06: Powder Residual
     • ISO10993-10: Biocompatibility (Primary Skin Irritation and Dermal Sensitization)

7. The sample size for the training set

   • This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The product is a physical medical device (examination gloves).

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

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

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