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510(k) Data Aggregation
(71 days)
A 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.
This device is a powder free vinyl examination glove.
The provided text describes a 510(k) summary for the OAKTEX Examination Glove, a powder-free vinyl examination glove. The study presented is a substantial equivalence comparison with a predicate device, the Maxxim powder-free vinyl examination glove.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device. The "Pass" for the Water Leak Test indicates meeting a specific standard, while other metrics are directly compared.
| TEST | Acceptance Criteria (Predicate Device: Maxxim Vinyl Exam Glove) | Reported Device Performance (OAK Vinyl Exam Glove 96-X61 Series) |
|---|---|---|
| Water Leak Test (ASTM D5151-92) | Pass | Pass |
| Tensile MPa Ultimate | 13.7 | 10.4 |
| Elongation, Ultimate (%) | 437 | 355 |
| Thickness - Palm (mm) | 0.130 | 0.151 |
| Thickness - Finger (mm) | 0.113 | 0.125 |
| Length (mm) | 241 | 241 |
| Width/mm | L (105) | S, M, L, XL (95, 105, 118, 124) |
| Powdered | No | No |
| ASTM 5250-92 | Meets ASTM 5250-92 | Meets* ASTM 5250-92 |
*Except for (width) dimensional requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each test (e.g., number of gloves tested for water leak, tensile, etc.) nor the data provenance specifications like country of origin. The study appears to be a direct comparison of physical properties and performance against a predicate device, likely conducted as part of the manufacturing quality control and regulatory submission process. There is no indication of retrospective or prospective data in the typical sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is not applicable to this study. The study involves laboratory-based physical and performance testing of a medical device (gloves) against established ASTM standards and a predicate device's specifications. The results are objective measurements rather than interpretations requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements, not subjective interpretations requiring adjudication.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study
No. This is not an MRMC study. It is a comparison of physical and performance characteristics of a medical glove.
6. Standalone Performance Study
Yes, in a sense. The "OAK Vinyl Exam Glove 96-X61 Series" performance data represents the standalone performance of the device on various metrics. This data is then directly compared to the predicate device.
7. Type of Ground Truth Used
The "ground truth" for this study is based on established ASTM standards (e.g., ASTM D5151-92 for water leak, and ASTM 5250-92) and the specified characteristics of a legally marketed predicate device (Maxxim powder-free vinyl examination glove).
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set." The study involves direct physical and performance testing.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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