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These powder-free sterile light brown colored surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. 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:

| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in
Minutes, 0.01 µg/cm²/minute |
|-----|-------------------------------------|-----------------------------------------------------------------------|
| 1. | Carmustine (BCNU) (3.3 mg/ml) | 0.20 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Doxorubicin HCl (2.0 mg/ml) | >240 |
| 5. | Etoposide (20 mg/ml) | >240 |
| 6. | Fluorouracil (50.0 mg/ml) | >240 |
| 7. | Methotrexate (25 mg/ml) | >240 |
| 8. | Paclitaxel (6.0 mg/ml) | >240 |
| 9. | Thiotepa (10.0 mg/ml) | 82.2 |
| 10. | Vincristine Sulfate (1.0 mg/ml) | >240 |

Please note that the following drug has extremely low permeation time of less than 30 minutes: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 0.20 minute.

The proposed device is a disposable device. It is not made with natural rubber latex. Instead, the gloves are formulated using neoprene synthetic polymer and are coated with nitrile coating. The gloves are manufactured using exact same material used in the currently cleared device, Duraprene SMT gloves, that have been legally marketed by Cardinal Health under K102500. The gloves are manufactured using molds that feature anti-slip finish, independent thumb, and tapered mechanically locking cuffs to help reduce cuff roll down. They are light brown in color and are offered powder-free and sterile.

The acceptance criteria and device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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