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510(k) Data Aggregation
(173 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The gloves was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs".
The following drugs have been tested with these gloves:
| Chemotherapy Drug & Concentration | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Bendamustine HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Bleomycin Sulfate, 15 mg/ml (15,000 ppm) | >240 min |
| Busulfan, 6 mg/ml (6,000 ppm) | >240 min |
| Carboplatin, 10 mg/ml (10,000 ppm) | >240 min |
| Carmustine 3.3 mg/ml (3,300 ppm) | 10.0 min |
| Chloroquine, 50 mg/ml (50,000 ppm) | >240 min |
| Cisplatin, 1mg/ml (1000 ppm) | >240 min |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 min |
| Cytarabine HCl (Cytosine), 100 mg/ml (100,000 ppm) | >240 min |
| Dacarbazine (DTIC), 10 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 min |
| Epirubicin HCl, 2 mg/ml (2,000 ppm) | >240 min |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 min |
| Fludarabine, 25 mg/ml (25,000 ppm) | >240 min |
| Fluorouracil (5 Flu), 50mg/ml (50,000ppm) | >240 min |
| Gemcitabine HCl, 38 mg/ml (38,000 ppm) | >240 min |
| Idarubicin HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Ifosfamide (IFEX), 50 mg/ml (50,000 ppm) | 80.0 min |
| Mechlorethamine HCl, 1 mg/ml (1,000 ppm) | >240 min |
| Melphalan HCl, 5 mg/ml (5,000 ppm) | >240 min |
| Methotrexate, 25mg/ml (25,000ppm) | >240 min |
| Mitomycin C, 0.5mg/ml (500 ppm) | >240 min |
| Mitoxantrone HCl (2.0 mg/mL) (2000 ppm) | >240 min |
| Oxaliplatin, 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 min |
| Rituximab, 10 mg/ml (10,000 ppm) | >240 min |
| Thiotepa, l0mg/ml (10,000ppm) | 20.0 min |
| Trisenox (Arsenic Trioxide), 1 mg/ml (1,000 ppm) | >240 min |
| Vincristine sulfate, 1mg/ml (1000 ppm) | >240 min |
| Vinorelbine, 10 mg/ml (10,00 ppm) | >240 min |
| Opioid Drug | Minimum Breakthrough Detection Time in Minutes, 0.01 μg/cm2/min: |
|---|---|
| Fentanyl Citrate Injection, 100mcg/2mg | >240 min |
*Please note that the following drugs have low permeation times:
Carmustine: 10.0 minutes, Thiotepa: 20.0 minutes
Warning: Do not use with Carmustine & Thiotepa.
Caution: Testing showed breakthrough time of 80.0 minutes with Ifosfamide IFEX (50.0 mg/mL).
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