(68 days)
A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Lavender colored nitrile, chlorinated, powder-free, textured fingertip, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the acceptance criteria and study proving the Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves meet them.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Dimensions (ASTM D 6319-00a) | Meets |
| Physical Properties (ASTM D 6319-00a) | Meets |
| Freedom from pinholes (ASTM D 6319-00a & ASTM D 5151-06) | Meets |
| Powder Free (ASTM D 6124-06 & ASTM D 6319-00a) | 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 11) | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each "test set" within the non-clinical studies. The studies are described as "Non-Clinical Tests" and "Animal Based Biocompatibility Test Data," which implies testing was performed on either physical gloves (for dimensions, physical properties, pinholes, powder-free) or on animals (for biocompatibility). The provenance of the data is not specified in terms of country of origin but is implied to be from laboratory testing. These are retrospective tests performed to demonstrate compliance with established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a physical product (exam glove) and the acceptance criteria are based on standardized performance and biocompatibility tests, not on expert interpretation of data like medical imaging. Therefore, no "experts" in the sense of clinical reviewers are used to establish ground truth for the performance parameters.
4. Adjudication Method for the Test Set
Not applicable. The performance is measured against objective standards (e.g., ASTM and ISO standards) and not through subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device that would involve human readers interpreting cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a physical medical device (exam glove), not an algorithm or AI system. The performance is inherent to the glove's physical and biological properties.
7. Type of Ground Truth Used
The ground truth used for performance criteria is established by recognized international and national standards:
- Performance and Physical Characteristics: ASTM D 6319-00a (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D 5151-06 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D 6124-06 (Standard Test Method for Residual Powder on Medical Gloves). These standards define objective, measurable parameters.
- Biocompatibility: ISO 10993, Part 10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization) and ISO 10993, Part 11 (Biological evaluation of medical devices - Tests for systemic toxicity). These standards provide protocols for animal-based studies to assess biological safety.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device; therefore, there is no "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.