(109 days)
The Skinsense polyisoprene underglove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials 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 Surgical Glove is a disposable device made of polyisoprene material that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials 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.
A powder-free sterile surgeon's glove is a disposable device made of polyisoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials 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.
A powder-free, sterile, surgeon's glove is a disposable device made of non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® surgical gloves that are the subject of this submission are sterile, single-use, powder-free gloves that are constructed of either synthetic polyisoprene or synthetic polychloroprene.
The provided documents describe the acceptance criteria and the results of a study conducted to demonstrate that several Biogel® gloves meet these criteria for chemotherapy drug permeation.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for each chemotherapy drug tested is implied by the testing method as a "Breakthrough detection time" in minutes (0.01 µg/cm²/mins). The general expectation for protective gloves against hazardous substances is a breakthrough time as long as possible, ideally exceeding the typical operational exposure duration. The standard testing time of 240 minutes (4 hours) appears to be a benchmark for "safe" permeation resistance.
The tables below synthesize the acceptance criteria (testing was performed according to ASTM D6978-05 (2019)) and the reported performance for each specific glove type and chemotherapy drug.
Biogel® Skinsense® Indicator® Underglove tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 6.6 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 16.9 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI Micro tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 10.0 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 20.3 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI UltraTouch® tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 24.2 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 17.9 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 26.7 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 28.7 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
Biogel® PI Indicator® Underglove tested for use with chemotherapy agents
| Drug and Concentration | Acceptance Criteria (Breakthrough detection time in minutes (0.01µg/cm²/mins)) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|---|
| Bleomycin 15 mg/ml | >240 | >240 |
| Busulfan 6 mg/ml | >240 | >240 |
| Carmustine 3.3 mg/ml | As long as possible, specific value reported | 17.3 |
| Cisplatin 1.0 mg/ml | >240 | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | >240 | >240 |
| Cytarabine 100 mg/ml | >240 | >240 |
| Dacarbazine (DTIC) 10 mg/ml | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | >240 | >240 |
| Ellence 2 mg/ml | >240 | >240 |
| Etoposide (Toposar) 20 mg/ml | >240 | >240 |
| Fludarabine 25 mg/ml | >240 | >240 |
| Fluorouracil 50 mg/ml | >240 | >240 |
| Idarubicin 1 mg/ml | >240 | >240 |
| Ifosfamide 50 mg/ml | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | >240 | >240 |
| Melphalan 5 mg/ml | >240 | >240 |
| Methotrexate 25 mg/ml | >240 | >240 |
| Mitomycin C 0.5 mg/ml | >240 | >240 |
| Mitoxantrone 2 mg/ml | >240 | >240 |
| Paclitaxel (Taxol) 6 mg/ml | >240 | >240 |
| Paraplatin 10 mg/ml | >240 | >240 |
| Rituximab 10 mg/ml | >240 | >240 |
| Thiotepa 10 mg/ml | As long as possible, specific value reported | 24.1 |
| Vincristine Sulfate 1 mg/ml | >240 | >240 |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of individual gloves or test replicates used for each chemotherapy drug. However, per ASTM D6978, testing generally involves multiple specimens (e.g., 3 specimens per drug as per standard recommendations for breakthrough time).
- Data Provenance: The study was a non-clinical test conducted according to ASTM D6978-05 (2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The country of origin for the data is not specified, but the use of an international standard like ASTM suggests a rigorous and replicable testing methodology. The data is prospective in the sense that the testing was performed specifically to support this FDA submission for the "tested for use with chemotherapy agents" claim.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study did not involve human experts establishing ground truth in a medical context. The ground truth (breakthrough time) was established through objective measurement in a laboratory setting following a standardized test method (ASTM D6978-05 (2019)).
4. Adjudication method for the test set:
This information is not applicable as the study did not involve human adjudication. The results were obtained through standardized laboratory measurements.
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 information is not applicable. The submission describes a non-clinical in vitro permeation test for medical gloves, not an AI-assisted diagnostic or clinical device. There are no human readers or AI involved in this type of testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The submission describes a non-clinical in vitro permeation test for medical gloves. It is not an algorithm or software device.
7. The type of ground truth used:
The ground truth used was objective laboratory measurement of the "Breakthrough detection time" of chemotherapy drugs through the glove material, as defined by the ASTM D6978-05 (2019) standard. This is a direct physical measurement, not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set:
This information is not applicable. There is no training set for this type of non-clinical device testing, as it does not involve machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set.
§ 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).