(134 days)
The powder free light yellow stretch vinyl 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. It has light yellow color and is sold as non sterile.
Powder free light-yellow stretch vinyl patient examination gloves are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. They have light yellow color.
The provided document describes the acceptance criteria and a study demonstrating that the "Powder Free Light-Yellow Stretch Vinyl Patient Examination Gloves" meet these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against several ASTM and ISO standards. The table below summarizes these.
| Description | Acceptance Criteria (Standard Reference) | Reported Device Performance (Our Device) |
|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary Skin Irritation (ISO 10993-10) | Passes | Passes |
| Dermal Sensitization (ISO 10993-10) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, skin irritation, etc.). It only mentions that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." The data provenance is from Wealth On (Jiangsu) Co., Ltd, China, and the tests were likely conducted prospectively as part of the 510(k) submission for the new device.
3. Number of Experts Used to Establish 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 objective, standardized testing methods (ASTM, ISO) rather than expert consensus on subjective evaluations.
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective and based on established physical and biological testing procedures, not on subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance
This information is not applicable. This is a submission for a medical device (patient examination gloves), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is for the physical and biological properties of the gloves themselves.
7. The Type of Ground Truth Used
The ground truth used is based on objective measurements and results obtained through standardized laboratory testing according to ASTM and ISO standards for physical properties and biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such devices would be the manufacturing process itself, ensuring consistency and quality control.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" in the context of this device. The standards (ASTM, ISO) themselves define the acceptable performance characteristics, and the manufacturing process aims to consistently produce gloves that meet these predefined criteria.
§ 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.