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Powdered 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.

powdered vinyl patient examination gloves, white(non-colored) that mects all of the requirements of ASTM standard D 5250-0004.

1. Table of Acceptance Criteria and Reported Device Performance:

   Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
   Dimension	ASTM standard D 5250-00c4	Meets
   Physical Properties	ASTM standard D 5250-00c4	Meets
   Freedom from pinholes	21 CFR 800.20	Meets
   Powder Amount	ASTM standard D 5250-00c4	Meets
   Biocompatibility (extract.)	Not specified (implied <10mg/dm2)	<10mg/dm2
   Primary Skin Irritation	ISO10993-10	Passes
   Dermal Sensitization	ISO10993-10	Passes

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample sizes used for testing each characteristic. The data provenance is not explicitly stated in terms of country of origin, but the testing was performed to ASTM and ISO standards, and CFR regulations, implying an adherence to internationally recognized testing procedures. The study appears to be non-clinical, involving testing of the physical and chemical properties of the gloves, rather than human clinical trials. It is a prospective evaluation against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This section is not applicable as the "ground truth" for this device (a patient examination glove) is established by performance against pre-defined engineering and safety standards (e.g., ASTM, ISO, CFR), not by expert medical interpretation or diagnosis.

4. Adjudication method for the test set:
   Not applicable. The performance is assessed against objective technical standards, not through adjudication of expert opinions.

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 physical medical device (examination gloves), not an AI-assisted diagnostic or interpretative tool. Therefore, MRMC studies and AI-related effectiveness are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a physical medical device.

7. The type of ground truth used:
   The ground truth for this device is based on established industry standards and regulatory requirements for medical devices, specifically for patient examination gloves. These include:

   • ASTM standard D 5250-00c4 (for dimensions, physical properties, powder amount)
   • 21 CFR 800.20 (for freedom from pinholes)
   • ISO10993-10 (for biocompatibility, including primary skin irritation and dermal sensitization)

8. The sample size for the training set:
   Not applicable. As this is a physical medical device and not a machine learning model, there is no "training set" in the conventional sense. The manufacturing process is likely subject to quality control and sampling for ongoing compliance.

9. How the ground truth for the training set was established:
   Not applicable. No training set is used for this type of device.

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