(117 days)
The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The document provides information on the performance of several types of surgical gloves when tested for resistance to permeation by chemotherapy drugs. The acceptance criteria and the study method are based on ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The implicit acceptance criterion for these gloves, based on the Breakthrough detection time values and the common understanding in such tests, is that the gloves should demonstrate resistance to permeation by chemotherapy drugs for a reasonable duration (e.g., as long as possible, or at least a certain minimum time). While a specific "pass/fail" threshold is not explicitly stated as an acceptance criterion in minutes, the values of ">240 minutes" indicate excellent performance for most drugs. The lower values for Carmustine and Thiotepa highlight instances where permeation occurs more quickly.
The reported device performance for each glove type and chemotherapy drug is provided in the tables across the document. Below is a summary table combining this information as an example, for "Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents" (from page 3):
| Drug and Concentration | Acceptance Criteria (Breakthrough Detection Time - implicit goal) | Reported Device Performance (Breakthrough detection time in minutes (0.01µg/cm²/mins)) |
|---|---|---|
| Bleomycin 15 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Busulfan 6 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Carmustine 3.3 mg/ml | As long as possible, ideally >240 minutes | 12.1 |
| Cisplatin 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Cytarabine HCL 100 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Dacarbazine (DTIC) 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Doxorubicin HCL 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Ellence 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Etoposide (Toposar) 20 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Fludarabine 25 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Fluorouracil 50 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Idarubicin 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Ifosfamide 50 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mechlorethamine HCl 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Melphalan 5 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Methotrexate 25 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mitomycin C 0.5 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mitoxantrone 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Paclitaxel (Taxol) 6 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Paraplatin 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Rituximab 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Thiotepa 10 mg/ml | As long as possible, ideally >240 minutes | 14.1 |
| Vincristine Sulfate 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set (number of gloves tested per drug type). It only reports the breakthrough detection time.
The data provenance is from testing conducted in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based prospective testing methodology. The country of origin of the data is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of study (chemical permeation testing of medical devices) does not typically involve human expert adjudication in the same way, for example, a diagnostic image interpretation study would. The "ground truth" is established by the objective, quantitative measurement of chemical permeation according to the specified ASTM standard. Therefore, there are no "experts" in the sense of clinical reviewers establishing a ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this is a laboratory test with objective measurements, not a human interpretation task requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a standalone performance test of a physical device against chemical permeation, not an AI-assisted diagnostic task involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This entire study is a standalone performance assessment of a physical device. There is no "algorithm" or "human-in-the-loop" concept involved. The performance is the intrinsic resistance of the glove material to chemical permeation.
7. The Type of Ground Truth Used:
The ground truth used is based on objective, quantitative measurements of chemical permeation using analytical methods specified or implied by the ASTM D6978 standard. The "Breakthrough detection time" is the measured outcome, indicating the time at which a quantifiable amount of the chemotherapy drug permeates through the glove material.
8. The Sample Size for the Training Set:
Not applicable. This is a direct performance test of a manufactured product, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device performance study.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).