(46 days)
Powder free 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.
Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
This document describes the safety and effectiveness information for the Powder-free Vinyl Patient Examination Gloves, Colored (Yellow) manufactured by Tangshan Jiteng Plastic Products Co., Ltd.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | Meets |
| Biocompatibility (Primary Skin Irritation) | ISO10993-10 (Primary Skin Irritation in rabbits) | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | ISO10993-10 (Dermal sensitization in the guinea pig) | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each specific test (e.g., dimension, physical properties, pinholes, powder residual, biocompatibility tests). However, it implies that the device was tested to meet the requirements of the specified ASTM and CFR standards, which typically involve specific sampling plans.
- Data Provenance: The testing was conducted by or for Tangshan Jiteng Plastic Products Co., Ltd., based in China. The data is reported as part of a premarket notification for a medical device, indicating it's retrospective testing performed to demonstrate compliance with established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is a patient examination glove, and the objective safety and performance characteristics are determined by standardized physical and chemical tests rather than expert interpretation of medical images or data. The "ground truth" for these tests is the quantitative measurement against the established limits in the respective standards (ASTM D 5250-06, D6124-06, 21 CFR 800.20, ISO10993-10).
4. Adjudication Method for the Test Set
This is not applicable as the testing involves objective measurements against established standards, not judgmental evaluations requiring adjudication.
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 typically performed for diagnostic devices where human readers interpret medical images or data. The device in question is a medical glove, for which such a study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is a physical medical glove and does not involve any algorithms or artificial intelligence.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is based on objective measurement against established regulatory and consensus standards. This includes:
- ASTM standard D 5250-06: For dimensions and physical properties (e.g., tensile strength, elongation).
- 21 CFR 800.20: For freedom from pinholes (water leak test).
- ASTM standard D 6124-06: For powder residual.
- ISO10993-10: For biocompatibility (Primary Skin Irritation and Dermal Sensitization).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product and does not involve any machine learning algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is 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.