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510(k) Data Aggregation
(232 days)
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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) are disposable devices which made of poly(vinyl chloride) polymer compound, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between pattent and examiner and they meets all of the requirements of ASTM standard D 5250-06 el .
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06e1 | Meets |
| Physical Properties | ASTM standard D 5250-06e1 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06e1 and D6124-01 | Meets (<2mg/glove) |
| Primary Skin Irritation | ISO 10993-10 (Passes in rabbits) | Not a Primary Skin Irritation |
| Dermal sensitization | ISO 10993-10 (Passes in guinea pig) | Not a Dermal sensitization |
2. Sample Size and Data Provenance
The provided text does not specify the exact sample sizes used for each test. However, it indicates that the tests were performed according to established standards like ASTM and ISO, which would inherently involve specific sample sizes.
The data provenance is not explicitly stated in terms of country of origin, but the submission is from RONGYAO PLASTIC PRODUCE CO., LTD in China. The tests are non-clinical, implying they are laboratory-based and likely conducted prospectively to evaluate the device's conformance to standards.
3. Number of Experts and Their Qualifications
This information is not applicable. The device is a "Powder free Vinyl Patient Examination Gloves," and its performance is evaluated against technical standards and biocompatibility tests, not clinical assessment by experts.
4. Adjudication Method
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth from ambiguous or complex data, such as medical images. For the technical performance of examination gloves, the outcome is determined by objective measurements against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is designed to evaluate the improvement in human reader performance (e.g., radiologists interpreting images) with and without AI assistance. This type of study is not relevant for a patient examination glove, which is a physical device and not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No. This study type is for AI algorithms. The device in question is a physical glove, and its "standalone" performance is assessed by meeting the listed technical and biological compatibility criteria.
7. Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements. Specifically, these include:
- ASTM standards (D 5250-06e1, D6124-01) for physical characteristics.
- 21 CFR 800.20 for freedom from pinholes.
- ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).
8. Sample Size for the Training Set
This information is not applicable. Training sets are used for machine learning algorithms. This device is a manufactured product and does not involve AI algorithms that require training data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this device.
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