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510(k) Data Aggregation
(92 days)
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. In addition, these gloves were tested respectively for use with chemotherapy drugs and Fentanyl citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
This device, Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is a nitrile non-sterile medical examination glove available in various sizes (from extra-small to extra-large) and packaging configuration. The gloves are non-sterile medical examination gloves, seamless, ambidextrous, five fingered. They are made from proprietary formulations composed of NBR (Nitrile Butadiene Rubber), accelerator, bulking agent, and pigment. In addition, no former release powder or chemical is used in its manufacturing process.
The provided document is a 510(k) premarket notification for a medical device: "Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with AI components. Therefore, many of the requested fields regarding AI studies, ground truth establishment, and expert involvement are not applicable or directly addressed in this submission.
However, I can extract the acceptance criteria and the device's performance based on the non-clinical bench testing for the physical and chemical resistance properties of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions | ||
| Length (XS&S) | ≥ 220 mm | Pass |
| Length (M&L&XL) | ≥ 230 mm | Pass |
| Thickness (Palm) | ≥ 0.05 mm min. | Pass |
| Thickness (Finger) | ≥ 0.05 mm min. | Pass |
| Palm Width (X-small) | 70 ± 10 mm | Pass |
| Palm Width (Small) | 85 ± 10 mm | Pass |
| Palm Width (Medium) | 95 ± 10 mm | Pass |
| Palm Width (Large) | 110 ± 10 mm | Pass |
| Palm Width (X-Large) | 120 ± 10 mm | Pass |
| Freedom from holes (Water leak) | G-I/AQL 2.5 | Pass |
| Tensile strength (Before aging) | 14 MPa, min. | Pass |
| Tensile strength (After aging) | 14 MPa, min. | Pass |
| Elongation (Before aging) | 500% min. | Pass |
| Elongation (After aging) | 400% min. | Pass |
| Powder Residual | 240 min. | > 240 |
| 2. Busulfan 6.0 mg/ml | > 240 min. | > 240 |
| 3. Carboplatin 10.0 mg/ml | > 240 min. | > 240 |
| 4. Carmustine (BCNU) 3.3 mg/ml | 59.4 min. | 59.4 |
| 5. Chloroquine 50.0 mg/ml | > 240 min. | > 240 |
| 6. Cisplatin 1 mg/ml | > 240 min. | > 240 |
| 7. Cyclophosphamide 20 mg/ml | > 240 min. | > 240 |
| 8. Cyclosporin A 100.0 mg/ml | > 240 min. | > 240 |
| 9. Cytarabine 100.0 mg/ml | > 240 min. | > 240 |
| 10. Dacarbazine (DTIC), 10.0 mg/ml | > 240 min. | > 240 |
| 11. Daunorubicin 5.0 mg/ml | > 240 min. | > 240 |
| 12. Docetaxel 10.0 mg/ml | > 240 min. | > 240 |
| 13. Doxorubicin Hydrochloride 2.0 mg/ml | > 240 min. | > 240 |
| 14. Epirubicin 2.0 mg/ml | > 240 min. | > 240 |
| 15. Etoposide (Toposar) 20.0 mg/ml | > 240 min. | > 240 |
| 16. Fludarabine 25.0 mg/ml | > 240 min. | > 240 |
| 17. Fluorouracil 50.0 mg/ml | > 240 min. | > 240 |
| 18. Gemcitabine 38.0 mg/ml | > 240 min. | > 240 |
| 19. Idarubicin 1.0 mg/ml | > 240 min. | > 240 |
| 20. Ifosfamide 50.0 mg/ml | > 240 min. | > 240 |
| 21. Irinotecan 20.0 mg/ml | > 240 min. | > 240 |
| 22. Mechlorethamine HCl 1.0 mg/ml | > 240 min. | > 240 |
| 23. Melphalan 5.0 mg/ml | > 240 min. | > 240 |
| 24. Methotrexate 25 mg/ml | > 240 min. | > 240 |
| 25. Mitomycin C 0.5 mg/ml | > 240 min. | > 240 |
| 26. Mitoxantrone 2.0 mg/ml | > 240 min. | > 240 |
| 27. Oxaliplatin 2.0 mg/ml | > 240 min. | > 240 |
| 28. Paclitaxel (Taxol), 6.0 mg/ml | > 240 min. | > 240 |
| 29. Paraplatin 10 mg/ml | > 240 min. | > 240 |
| 30. Retrovir 10 mg/ml | > 240 min. | > 240 |
| 31. Rituximab 10 mg/ml | > 240 min. | > 240 |
| 32. Thiotepa, 10.0 mg/ml | 118.5 min. | 118.5 |
| 33. Topotecan HCl 1.0 mg/ml | > 240 min. | > 240 |
| 34. Trisonex 1.0 mg/ml | > 240 min. | > 240 |
| 35. Velcade (Bortezomib) 1.0 mg/ml | > 240 min. | > 240 |
| 36. Vincristine 1.0 mg/ml | > 240 min. | > 240 |
| 37. Fentanyl Citrate Injection 100 mcg/2ml | > 240 min. | > 240 |
Study Proving Device Meets Acceptance Criteria:
The device's performance against the acceptance criteria was demonstrated through non-clinical bench testing. The tests were conducted according to recognized international and ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size (number of gloves or test replicates) used for each individual bench test. The data provenance is derived from the testing of the "Disposable Powder Free Nitrile Examination Glove, Natural Blue Color." Since this is a submission by Ever Growth (Vietnam) Corporation Limited, it is highly probable the testing was conducted in Vietnam or a related testing facility, and the data is prospective in the sense that it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable to this type of device and study. The "ground truth" for the performance criteria (e.g., tensile strength, breakthrough time) is established by the specifications defined in the referenced ASTM and ISO standards, not by human expert consensus or interpretation of complex data. The tests are objective measurements.
4. Adjudication Method for the Test Set:
This is not applicable. The tests performed are objective, quantitative measurements against predefined numerical and qualitative criteria (e.g., pass/fail for cytotoxicity, specific values for length/thickness, minimum breakthrough times). There is no need for expert adjudication in the context of these physical and chemical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This device is a nitrile examination glove, a physical medical product, and does not involve AI or software components that would require an MRMC study or assessment of human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is a physical medical glove and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by objective measurements against established engineering and safety standards.
- For physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residual), the ground truth is defined by the requirements of standards like ASTM D3767, D5151-19, D412-16, D573-04, D6124-06, and 21 CFR 800.20.
- For biocompatibility (cytotoxicity, skin sensitization, skin irritation), the ground truth is defined by the criteria within ISO 10993-5:2009, ISO 10993-10:2021, and CPSC standards.
- For chemical permeation, the ground truth is the "Minimum Breakthrough Detection Time" measured according to ASTM D6978-05.
8. The Sample Size for the Training Set:
This is not applicable. This device is a physical medical product, not an AI/ML algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This is not applicable. As there is no training set for an AI/ML algorithm, this question does not apply.
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