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510(k) Data Aggregation
(216 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid. The gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Azacytidine | (25.0 mg/ml) | >240 |
| Carmustine | (3.3 mg/ml) | 25.0 |
| Cisplatin | (1.0 mg/ml) | >240 |
| Cyclophosphamide | (20.0 mg/ml) | >240 |
| Carboplatin | (10.0 mg/ml) | >240 |
| Dacarbazine | (10.0 mg/ml) | >240 |
| Docetaxel | (10.0 mg/ml) | >240 |
| Doxorubicin HCl | (2.0 mg/ml) | >240 |
| Epirubicin | (2.0 mg/ml) | >240 |
| Etoposide | (20.0 mg/ml) | >240 |
| Fluorouracil | (50.0 mg/ml) | >240 |
| Gemcitabine | (38.0 mg/ml) | >240 |
| Ifosfamide | (50 mg/ml) | >240 |
| Irinotecan | (20.0 mg/ml) | >240 |
| Methotrexate | (25.0 mg/ml) | >240 |
| Mitomycin C | (0.5 mg/ml) | >240 |
| Mitoxantrone | (2.0 mg/ml) | >240 |
| Oncovin | (1.0mg/ml) | >240 |
| Oxaliplatin | (5.0 mg/ml) | >240 |
| Paclitaxel | (6.0 mg/ml) | >240 |
| Thiotepa | (10.0 mg/ml) | 55.7 |
| Vinorelbine | (10.0 mg/ml) | >240 |
| Vincristine Sulfate | (1.0 mg/ml) | >240 |
Testing showed a minimum breakthrough time of 25.0 minutes with Carmustine and 55.7 minutes with Thiotepa
Warning: Do not use with Carmustine
| Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|---|
| Fentanyl Citrate Injection | 100 mcg/2ml | >240 |
| Fentanyl Citrate mixed with Simulated Gastric Acid at a 50:50 ratio | >240 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) is a disposable single-use, non-sterile, Black and powder-free ambidextrous glove made from nitrile butadiene rubber.
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