(10 days)
Cymunvera Powder Free Green Natural Rubber Latex Examination Glove lined with Aloe Vera is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The natural rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of Proteins and chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D 3578-00a and ASTM D5151-92 requirements. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Powder free gloves eliminate issues of powder contamination.
This document is a 510(k) submission for the CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove lined with Aloe Vera. It focuses on demonstrating substantial equivalence to a predicate device, not on proving effectiveness for a specific clinical condition using AI. Therefore, the questions related to AI performance, multi-reader multi-case studies, and human reader improvement are not applicable to this submission.
Here's an analysis of the provided information, focusing on the relevant criteria for a medical glove:
Acceptance Criteria and Device Performance for CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove
1. Table of Acceptance Criteria and Reported Device Performance:
| Specification | Predicate Device Performance | Proposed Device (Cymunvera) Performance |
|---|---|---|
| Physical Properties | ||
| Powder Free | Powder Free | Powder Free |
| Color | White Color | Green Color |
| Performance Standards | ||
| ASTM D 3578 (General) | ASTM D 3578-99 | ASTM D 3578-00a (Meets/Exceeds) |
| Water Tightness | ASTM D5151-99 | ASTM D5151-99 (Meets/Exceeds) |
| Safety | ||
| Rabbit Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
Notes on Acceptance Criteria and Performance:
- The acceptance criteria are implicitly met by demonstrating performance that is "equal to or exceeds" the predicate device in relevant ASTM standards and safety tests.
- The "PROPOSED" column shows that the Cymunvera glove meets or exceeds the predicate's performance against these established standards. Specifically, it states "Passes" for irritation and sensitization, and utilizes a newer version of ASTM D 3578 (D 3578-00a vs D 3578-99) while maintaining the same water tightness standard.
- The primary differences highlighted are the color (green vs. white) which is a cosmetic difference and the intended use of the aloe vera lining, which is not directly assessed in this table but is implied to contribute to wearer comfort.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify sample sizes for the non-clinical tests (e.g., number of gloves tested for water tightness, number of rabbits/guinea pigs used).
- The data provenance is not explicitly stated beyond being part of a 510(k) submission by Tillotson Healthcare Corporation, based in Bedford, NH, U.S.A. It is typical for such tests to be conducted in a laboratory setting, often by third-party testing facilities. The tests are prospective in the sense that they were conducted for the purpose of this submission to verify the device's properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This submission focuses on objective, standardized physical and biological tests for a medical glove, not on expert interpretation of medical images or data. The "ground truth" for these tests is defined by the ASTM standards themselves and the results of the laboratory tests.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3. Testing against ASTM standards involves objective measurements, not subjective adjudication by human experts.
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 is a medical glove submission, not an AI/software device. No human-in-the-loop performance or AI assistance is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a medical glove submission, not an AI/software device.
7. The Type of Ground Truth Used:
- The ground truth for the non-clinical tests (physical performance and safety) is based on established industry standards (ASTM D 3578-00a and ASTM D5151-99) and the results of standardized laboratory testing for rabbit irritation and guinea pig sensitization. For example, water tightness is determined by whether the glove passes the specified leak rate test. "Passes" for irritation/sensitization means that the tests did not elicit a reaction above a defined threshold according to the test protocols.
8. The Sample Size for the Training Set:
- Not applicable. This product is a physical medical device, not an AI algorithm that requires a training set. The "training" for such a device would refer to its manufacturing process development and quality control, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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.