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510(k) Data Aggregation
(34 days)
The 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 Latex Patient Exam Glove, Smooth and Textured Natural Color (Off White) with Protein Labeling Claim (50 µg/dm² or less of water soluble protein)
Acceptance Criteria and Device Performance for Powder Free Latex Patient Exam Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM Standard D3578 | Meets |
| Physical Properties | ASTM Standard D3578 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151 | Meets |
| Powder Residual | ASTM Standard D6124 (specifically, < 2 mg per glove) | Meets (Results generated values below 2 mg of residual powder) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10); Dermal Sensitization in the guinea pig (ISO 10993-10) | Gloves are non-irritating; Gloves do not display any potential for sensitization |
| Residual Protein Levels | ASTM Standard D5712 (specifically, ≤ 50 µg/dm² of water soluble protein) | Meets (Protein Labeling Claim: 50 µg/dm² or less of water soluble protein) |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, the tests are conducted according to recognized ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted to meet the defined standards. The submission is for a Traditional 510(k), implying testing was performed to demonstrate substantial equivalence.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert-driven image or data interpretation.
4. Adjudication Method
Not applicable. Performance is based on objective laboratory testing against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a medical glove, and its performance is evaluated against engineering and biological standards, not typically through MRMC studies.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical device (medical glove), not an algorithm or software.
7. Type of Ground Truth Used
The ground truth for this device is based on established industry standards and regulatory requirements. This includes:
- ASTM Standards: D3578 (dimensions, physical properties), D5151 (freedom from pinholes), D6124 (powder residual), D5712 (residual protein levels).
- ISO Standard: 10993-10 (biocompatibility - irritation and sensitization).
- CFR Regulations: 21 CFR 800.20 (freedom from pinholes).
8. Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of an AI or machine learning model. Performance is evaluated through laboratory testing of manufactured gloves.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device. The "ground truth" for evaluating the device's performance is defined by the requirements of the internationally recognized and regulatory standards listed above.
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