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510(k) Data Aggregation
(267 days)
This is a disposable device intended for medical application that is worn on the examiner's hand to prevent contamination between examiner and patient and to protect examiner from the following Chemotherapy drugs tested to ASTM D 6978 with the indicated Breakthrough Detection Times :
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
Nitrile Powder Free Examination Glove (Blue)
- CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine.
Nitrile Powder Free Examination Glove (Green) - WARNING: DO NOT USE WITH CARMUTINE.
Nitrile Powder Free Examination Glove (White) - CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa.
- WARNING: DO NOT USE WITH CARMUTINE.
Non Sterile. Powder-Free. Nitrile Examination for Use with Chemotherapy Drugs
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:
Device: Royal Guard Nitrile Examination Glove Tested For Use with Chemotherapy Drugs (Blue, Green, White)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard (Acceptance Criteria) | Device Performance (Reported) |
|---|---|---|
| Dimensions | ASTM D 6319-00a (2005) | Meets |
| Physical Properties | ASTM D 6319-00a (2005) | Meets |
| Freedom from Holes | ASTM D 6319-00a (2005) | Meets |
| Powder-Free Residue | ASTM D 6124-06 | Meets |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in Rabbits | Meets |
| Biocompatibility (Sensitization) | Guinea Pig Sensitization | Meets |
| Chemotherapy Drug Permeation | ASTM D 6978-05 (Specific Breakthrough Time) | See Breakthrough Time in Section 14 |
Chemotherapy Drug Permeation (Breakthrough Detection Time in Minutes) - Section 14 Data:
| Chemotherapy Drug | Blue Glove Performance | Green Glove Performance | White Glove Performance |
|---|---|---|---|
| Carmustine (BCNU) | 40.00 | 17.00 | 9.00 |
| Cyclophosphamide (Cytoxan) | > 240 | > 240 | > 240 |
| Doxorubicin HCl (Adriamycin) | >240 | > 240 | > 240 |
| Etoposide (Toposar) | >240 | > 240 | > 240 |
| Fluorouracil | >240 | > 240 | > 240 |
| Paclitaxel (Taxol) | >240 | > 240 | > 240 |
| Thio-Tepa | 177.00 | 63.00 | 48.00 |
| Cisplatin | >240 | > 240 | > 240 |
| Dacarbazine (DTIC) | >240 | > 240 | > 240 |
Note on Chemotherapy Drug Permeation: The "acceptance criteria" for chemotherapy drug permeation are the results themselves, as they are being reported to define the specific capabilities of the gloves. The underlying standard for testing is ASTM D 6978-05. The document includes warnings for specific glove colors regarding certain chemotherapy drugs due to lower breakthrough times.
2. Sample Size and Data Provenance (for test set/performance data)
The document does not explicitly state the sample sizes used for each of the performance tests (Dimensions, Physical Properties, Freedom from Holes, Powder-Free Residue, Biocompatibility, and Chemotherapy Drug Permeation). It only says the testing "meets" the respective ASTM standards or criteria.
For Chemotherapy Drug Permeation, the data provenance is implicitly from laboratory testing conducted by the manufacturer or a contracted lab to meet ASTM D 6978-05. The country of origin for the manufacturing and potentially the testing is Thailand, as the submitter's address is in Thailand. Given the nature of these tests, they are inherently prospective for the device being submitted.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the device is a medical glove, and its performance is evaluated against engineering and chemical standards, not by expert interpretation of clinical data or images. Ground truth is established through objective physical and chemical testing.
4. Adjudication Method (for test set)
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts in image interpretation or clinical diagnosis. This device's performance is determined by objective laboratory measurements against defined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study evaluates the improvement in human reader performance (e.g., radiologists interpreting images) with or without AI assistance. The device is a physical medical glove, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical glove, not an algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The performance data presented (e.g., breakthrough times, physical properties) are inherent to the device itself.
7. Type of Ground Truth Used
The ground truth used for evaluating this device's performance is based on objective measurements and adherence to established industry standards.
- Engineering/Physical Standards: For dimensions, physical properties, freedom from holes, and powder-free residue, the ground truth is defined by the specifications and test methods outlined in ASTM D 6319-00a (2005) and ASTM D 6124-06.
- Biocompatibility Standards: For primary skin irritation and guinea pig sensitization, the ground truth is established by the results of standard animal testing protocols designed to assess biological response.
- Chemical Permeation Standard: For chemotherapy drug permeation, the ground truth is the experimentally determined breakthrough time as measured according to ASTM D 6978-05.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on physical and chemical properties.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for this type of device, this question is not relevant.
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