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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 5250-06.

Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to address your specific points:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The device being evaluated is "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)".
• The primary standards for acceptance are ASTM D 5250-06, 21 CFR 800.20, and ASTM D6124-01. In the biocompatibility section, ISO 10993-10 is also referenced as a requirement met, and the specific tests mentioned (Primary Skin Irritation, Dermal sensitization) are typically part of biocompatibility assessments within such standards.

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

The document does not specify the sample size used for the test set. It only states that the device "meets" the requirements of the standards listed. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective/prospective. The manufacturer is from Tangshan, P.R. China, so it's possible testing occurred there.

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

Given this is a 510(k) submission for medical gloves, "ground truth" in the context of expert review (like for diagnostic imaging AI) is not applicable. The assessment relies on laboratory testing against established physical and chemical standards, as well as biocompatibility tests. No human experts are described as establishing ground truth in this manner.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The evaluation is based on objective laboratory measurements and adherence to specified performance standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where reader performance is a key metric, often for AI-assisted interpretation. Medical gloves are not diagnostic devices, and their evaluation does not involve such studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Again, this concept is not applicable to a medical glove. Standalone performance and human-in-the-loop performance are terms used for AI algorithms. The device is a physical product, and its "performance" is measured directly against physical, chemical, and biological standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily objective laboratory measurements and tests against established consensus standards (ASTM, CFR, ISO). These standards define acceptable ranges or outcomes for various physical properties (e.g., dimensions, tensile strength, elongation), freedom from defects (pinholes), chemical residues (powder), and biological reactions (irritation, sensitization). This is a form of empirical validation against predefined metrics.

8. The Sample Size for the Training Set

Not applicable. Medical gloves do not utilize a "training set" in the context of machine learning or AI algorithms. The product undergoes manufacturing and quality control processes to ensure it meets specifications.

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

Not applicable, as there is no training set for this device type.

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