(112 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 minutes |
|---|---|
| Fluorouracil (50.0mg/ml) | >240 |
| Etoposide (20.0mg/ml) | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 |
| Carmustine (3.3mg/ml) | 22.0 |
| Thiotepa (10.0mg/ml) | 24.2 |
| Paclitaxel (6.0mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 |
| Methotrexate (25.0mg/ml) | >240 |
| Vincristine Sulfate (1.0mg/ml) | >24 |
"WARNING: Do not use with Carmustine and Thiotepa"
Not Found
The provided text describes the FDA's 510(k) clearance for "ENCORE Latex Ortho" and "GAMMEX Latex Ortho" powder-free latex surgical gloves. This document is a clearance letter for a medical device (surgical gloves), not a study report for an AI/CADeX device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and studies that prove the device meets those criteria in the context of AI/CADeX devices.
The document primarily focuses on:
- Substantial equivalence to legally marketed predicate devices.
- General controls provisions for medical devices.
- Indications for Use for the surgical gloves, which includes their testing for use with chemotherapy drugs as per ASTM D6978.
However, based on the provided text, I can extract the acceptance criteria related to chemotherapy drug permeation for these gloves as a device performance specification.
Here's the closest I can get to fulfilling your request based only on the provided text, reinterpreting the "device" as the surgical gloves and the "study" as the chemotherapy drug permeation testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Chemotherapy Drug (Concentration) | Acceptance Criteria (Minimum Breakthrough Detection Time in minutes) | Reported Device Performance (Breakthrough Detection Time in minutes) |
|---|---|---|
| Fluorouracil (50.0mg/ml) | >240 | >240 |
| Etoposide (20.0mg/ml) | >240 | >240 |
| Cyclophosphamide (20.0mg/ml) | >240 | >240 |
| Carmustine (3.3mg/ml) | Not for use (implied acceptance is failure) | 22.0 |
| Thiotepa (10.0mg/ml) | Not for use (implied acceptance is failure) | 24.2 |
| Paclitaxel (6.0mg/ml) | >240 | >240 |
| Doxorubicin Hydrochloride (2.0mg/ml) | >240 | >240 |
| Methotrexate (25.0mg/ml) | >240 | >240 |
| Vincristine Sulfate (1.0mg/ml) | >24 (Based on common interpretation of similar data, implying >=24) | >24 |
Note: The "acceptance criteria" where the device is "Not for use" (e.g., Carmustine, Thiotepa) implies that the breakthrough time observed (22.0 and 24.2 minutes respectively) was not considered adequate for safe use with these specific drugs, leading to the warning statement. For other drugs, the reported performance meets or exceeds the implicit acceptance criteria (i.e., ">240" meets ">240").
Regarding the remaining points (2-9), this information is NOT available in the provided text as it pertains to AI/CADeX device studies, not the clearance of surgical gloves.
- 2. Sample size used for the test set and the data provenance: Not applicable. The text describes testing of physical gloves against chemotherapy drugs, not a data-driven AI model.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for glove permeation is established by laboratory measurement using a standard (ASTM D6978).
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used: For chemotherapy permeation, the ground truth is objective laboratory measurement according to ASTM D6978.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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).