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510(k) Data Aggregation
(146 days)
Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:
| Test Chemotherapy Drug (Concentration) | Minimum Breakthrough Detection Time in minute |
|---|---|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 14.1 |
| Thiotepa (10.0mg/ml) | 16.9 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >240 |
"WARNING: Do not use with Carmustine and Thiotepa"
It is the powder-free variation of the class I sterile latex surgical gloves made on-line by surface treatment on the outside and polymer coating on inner surface.
The provided text is related to the 510(k) premarket notification for surgical gloves and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment as it pertains to an AI/ML device.
The document details the substantial equivalence of new surgical gloves to a legally marketed predicate device based on various physical, chemical, and biocompatibility tests, as well as their resistance to chemotherapy drugs. It explicitly states that "Clinical testing is not applicable to this device." This confirms that there was no study involving human readers or AI in the way your prompt describes.
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