(31 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
The powder free neon nitrile exam glove is a medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient. The powder free neon nitrile exam glove possesses the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3578-00, Physical Properties (except % elongation) Meets ASTM D 3578-00, Freedom from pinholes Meets ASTM D 3578-00 Meets ASTM D 5151-99, Powder Free Meets ASTM D 6124-00 Meets ASTM D 3578-00. Biocompatability: Primary Skin Irritation in Rabbits Passes, Guinea Pig Sensitization Passes.
This document describes the premarket notification (510(k)) for the Kimberly-Clark "Safeskin Neon Nitrile" Powder Free Neon Nitrile Exam Glove. It outlines the acceptance criteria and performance of the device based on established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-00 | Meets ASTM D 3578-00 |
| Physical Properties (except % elongation) | ASTM D 3578-00 | Meets ASTM D 3578-00 |
| Freedom from pinholes | ASTM D 3578-00 and ASTM D 5151-99 | Meets ASTM D 3578-00, Meets ASTM D 5151-99 |
| Powder Free | ASTM D 6124-00 and ASTM D 3578-00 | Meets ASTM D 6124-00, Meets ASTM D 3578-00 |
| Biocompatibility: Primary Skin Irritation in Rabbits | (Implied "Passes" for safety) | Passes |
| Biocompatibility: Guinea Pig Sensitization | (Implied "Passes" for safety) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each characteristic. However, the tests are conducted in accordance with ASTM standards (e.g., ASTM D 3578-00, ASTM D 5151-99, ASTM D 6124-00), which would typically specify sample sizes for robust testing.
The data provenance is not specified in terms of country of origin, but the testing would have been conducted by Kimberly-Clark or an accredited lab on their behalf. The data is retrospective in the sense that the tests were performed on finished product samples prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols outlined in ASTM standards, not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results where expert agreement is needed to establish ground truth. For medical gloves, performance is objectively measured against specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, and the effect of AI on their performance is being evaluated. This device is an examination glove, and its effectiveness is determined by its physical and chemical properties, not by human interpretation of its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the device's performance is standalone. The tests performed (e.g., dimensions, physical properties, freedom from pinholes, powder-free status, biocompatibility) are objective measurements of the glove itself, without human intervention in its function. The "algorithm" here is the glove's design and manufacturing process, and its performance is assessed directly.
7. The Type of Ground Truth Used
The ground truth used is established by objective, standardized measurements and criteria defined within recognized industry standards, specifically ASTM standards (e.g., ASTM D 3578-00, ASTM D 5151-99, ASTM D 6124-00). For biocompatibility, the ground truth is established through standard biological evaluation tests (e.g., primary skin irritation, guinea pig sensitization) designed to assess material safety.
8. The Sample Size for the Training Set
This information is not applicable. Medical gloves do not typically involve "training sets" in the context of machine learning or AI algorithms. The design and manufacturing processes are refined through engineering and material science, not through iterative training on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of this device. The physical and chemical properties of the glove materials and manufacturing processes are developed based on established scientific principles and prior knowledge of material performance and regulatory requirements.
§ 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.