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510(k) Data Aggregation
(217 days)
The synthetic nitrile patient examination gloves, powder free, blue color and tested for use with chemotherapy drugs are disposable devices intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The glove was tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
This document describes the acceptance criteria and the study results for Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs (K200093).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these gloves are defined by their resistance to permeation by chemotherapy drugs, as outlined in ASTM D6978-05 (Reapproved 2019). The "acceptance criteria" here refer to the performance benchmark set by the test method. For most drugs, the goal is to achieve a breakthrough time greater than 240 minutes.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Breakthrough Detection Time in Minutes) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| Blenoxane (Bleomycin), 15 mg/ml (15,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | >240 (Implied by standard and other values) | 22.6 |
| Cyclophosphamide, 20 mg/ml (20,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Etoposide (Toposar), 20 mg/ml (20,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Fluorouracil (5 Flu), 50 mg/ml (50,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Idarubicin, 1 mg/ml (1,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Mesna, 100 mg/ml (100,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Mitomycin C, 0.5 mg/ml (500 ppm) | >240 (Implied by standard and other values) | >240 |
| Paclitaxel, 6 mg/ml (6,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Thiotepa, 10 mg/ml (10,000 ppm) | >240 (Implied by standard and other values) | 46.9 |
| Trisenox, 1 mg/ml (1,000 ppm) | >240 (Implied by standard and other values) | >240 |
| Vincristine Sulfate, 1 mg/ml (1,000 ppm) | >240 (Implied by standard and other values) | >240 |
Note on meeting criteria: The device meets the criteria for most drugs, achieving breakthrough times >240 minutes. However, it specifically does not meet the implied >240 minutes criteria for Carmustine (22.6 minutes) and has a significantly shorter breakthrough time for Thiotepa (46.9 minutes), leading to "CAUTION" and "WARNING" statements for these specific drugs.
The document does not provide information for the following points, as they are not relevant to the type of device (medical gloves) and the study conducted (material performance testing, not an AI or diagnostic device study). The study described is a laboratory performance test rather than a clinical study with human or image data.
2. Sample size used for the test set and the data provenance: Not applicable. This is a material permeation test for gloves, not a data-driven AI study. The "test set" would refer to the number of glove samples subjected to each drug test, which is not specified but would follow standard laboratory protocols for ASTM D6978-05. The data provenance would be from laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material permeation is established by the physical testing procedure of ASTM D6978-05, not by expert consensus on data.
4. Adjudication method for the test set: Not applicable. The test results are objective measurements from the ASTM D6978-05 standard, not subjective interpretations requiring adjudication.
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: Not applicable. This is not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used: The "ground truth" for this study is defined by the objective measurements obtained through the standardized laboratory test method ASTM D6978-05 (Reapproved 2019) for assessing the permeation of medical gloves by chemotherapy drugs.
8. The sample size for the training set: Not applicable. This is not an AI or machine learning device and therefore does not have a "training set."
9. How the ground truth for the training set was established: Not applicable. As there is no training set for this type of device.
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