(139 days)
KIMBERLY-CLARK LAVENDER NITRILE Powder-Free Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile, powder-free, textured-fingertip, ambidextrous patient examination glove with a polymer coating on the donning surface without chlorination.
The document describes the Kimberly-Clark LAVENDER NITRILE Powder-Free Exam Gloves, which is a Class I medical device. The submission is a 510(k) premarket notification, indicating that the device is seeking to demonstrate substantial equivalence to existing legally marketed predicate devices rather than proving novel safety and efficacy.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria & Test | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from Pinhole | ASTM D 6319-10 | Meets |
| Freedom from Pinhole | ASTM D 5151-06 | Meets |
| Powder Free | ASTM D 6124-06 | Meets |
| Powder Free | ASTM D 6319-10 | Meets |
| ISO Skin Irritation Study | ISO 10993, Part 10 | Meets |
| Murine Local Lymph Node Assay | ISO 10993, Part 10 | Meets |
| ISO Systemic Toxicity Study | ISO 10993, Part 1 | Meets |
| Clinical Tests | (Not Applicable) | No new clinical tests required |
| Overall Conclusion (Functional & Biocompatibility) | FDA recognized consensus standards, acceptable pinhole quality level (AQL) | Meets all applicable exam glove performance and biocompatibility requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical tests (bench testing and animal-based biocompatibility studies) for the Kimberly-Clark LAVENDER* NITRILE Powder-Free Exam Gloves. It does not provide specific sample sizes for these tests, nor does it detail the provenance of the data in terms of geographical origin or retrospective/prospective nature. However, for bench testing of medical gloves, these tests typically involve a defined number of gloves per batch or lot to ensure statistical significance, and ISO 10993 standards for biocompatibility also outline testing parameters.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Since this involves laboratory and animal-based testing for a Class I general purpose exam glove, the concept of "experts" establishing ground truth in the way it's used for AI/diagnostic devices (e.g., radiologists, pathologists) is not directly applicable. The "ground truth" for these tests is established by adhering to the methodologies and pass/fail criteria defined in the referenced ASTM and ISO standards, which are developed by expert committees in their respective fields (e.g., materials science, toxicology). The individuals conducting these tests would be trained laboratory personnel.
4. Adjudication Method for the Test Set:
Not applicable in the context of bench and animal-based biocompatibility testing for an exam glove. The results are typically quantitative measurements or observations against predefined pass/fail criteria within the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is specifically relevant for diagnostic devices that involve human interpretation of medical images or data, often comparing AI-assisted performance to unassisted human performance. This is not applicable to an exam glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This concept is for AI/software devices. The Kimberly-Clark LAVENDER* NITRILE Powder-Free Exam Gloves are a physical medical device. The "performance" described here relates to the physical and chemical properties of the glove itself.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is based on the objective measurements and observations derived from standardized test methods (ASTM D6319, ASTM D5151, ASTM D6124) for physical properties and freedom from pinholes, and results from animal-based biocompatibility studies (ISO 10993 Parts 1, 10) for skin irritation, sensitization, and systemic toxicity. These standards define the expected performance and safety profile for medical examination gloves.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this 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.