(24 days)
A 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.
Nitrile Exam Gloves, Powder-Free
The provided document describes the acceptance criteria and the study results for the "Nitrile Exam Gloves, Powder-Free" manufactured by Ningbo Yujiang Plastic & Rubber Co. Ltd. This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving efficacy through a controlled clinical trial against specific disease outcomes.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards/Tests) | Reported Device Performance |
|---|---|
| ASTM D 3578-95 | Met or exceeded |
| ASTM D 5151 | Met or exceeded |
| FDA Water Leak Test (before aging) | Met or exceeded |
| FDA Water Leak Test (after aging) | Met or exceeded |
| Bio-Compatibility | Met or exceeded |
| Dermal Sensitization | Met or exceeded |
| Primary Skin Irritation | Met or exceeded |
| Bio-Burden (bacteria/mold) | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (ASTM D 3578-95, ASTM D 5151, FDA Water Leak Test, etc.). It only states that the device "met or exceeded" the requirements of these standards. The data provenance is not explicitly mentioned with respect to country of origin, but it is implied to be from testing conducted by or for Ningbo Yujiang Plastic & Rubber Co. Ltd. to meet US FDA requirements. The tests are general laboratory analyses, not human clinical trials, so the terms "retrospective" or "prospective" are not applicable in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For this type of device (nitrile exam gloves), "ground truth" is established by adherence to established engineering and material performance standards (e.g., ASTM standards) and biocompatibility tests, not by expert consensus on clinical images or patient outcomes. The "experts" involved would be relevant laboratory technicians and engineers performing and interpreting the results of these standardized tests. Their qualifications are implicitly that they are certified or trained to perform such tests according to the specified standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against defined pass/fail criteria within established standards. There is no need for human adjudication in the sense of resolving conflicting interpretations of complex data like in a clinical trial.
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 not an AI-powered diagnostic tool, but rather a medical glove. Therefore, an MRMC study and the concept of AI assistance for human readers are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical medical device (gloves).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry standards and regulatory tests. These include:
- ASTM D 3578-95: Standard Specification for Rubber Examination Gloves
- ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves
- FDA Water Leak Test: A regulatory requirement for medical gloves.
- Bio-Compatibility Tests: (e.g., Dermal Sensitization, Primary Skin Irritation) to assess biological safety.
- Bio-Burden (bacteria/mold) Test: To assess the microbial load.
These standards define the acceptable physical properties, barrier integrity, and biological safety of the gloves.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/ML device, there is no "training set." The device performance is assessed directly against predefined standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of medical device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.