(112 days)
This powder free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating, nom personnel to protect a surgical wound from contamination.
In addition, these gloves were tested for use with Chemotherapy Drugs in accordance ASTM D6978-05 (2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
This powder free surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating, nom personnel to protect a surgical wound from contamination.
The provided document is a 510(k) premarket notification approval for a medical glove, not for an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies for an AI/ML device is not present in the document.
The document focuses on the substantial equivalence of the Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs to a legally marketed predicate device. The performance data provided is related to the glove's resistance to permeation by chemotherapy drugs, in accordance with ASTM D6978-05 (2013).
However, I can extract the specific acceptance criteria and reported device performance from the provided table regarding chemotherapy drug permeation.
1. Table of Acceptance Criteria and Reported Device Performance (for Chemotherapy Drug Permeation):
| Chemotherapy Drugs | Concentration | Acceptance Criteria (Breakthrough Detection Time in Minutes) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | 13.0 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | >240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | >240 |
| Etoposide (Toposar) | 20.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | >240 |
| Fluorouracil | 50.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | >240 |
| Methotrexate | 25.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | >240 |
| Paclitaxel | 6.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | >240 |
| Thiotepa | 10.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | 24.9 |
| Vincristine Sulfate | 1.0mg/ml | Not explicitly stated as acceptance criteria, but tested for permeation. A longer time is better. | >240 |
Note on Acceptance Criteria: The document states, "In addition, these gloves were tested for use with Chemotherapy Drugs in accordance ASTM D6978-05 (2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." It then presents the 'Breakthrough Detection Time in Minutes'. While a specific numerical "acceptance criteria" is not explicitly listed as a pass/fail threshold in this document, the industry standard (ASTM D6978) would define what constitutes adequate protection. The reported values are the device's performance against these standards, and for most drugs, the glove shows excellent resistance (>240 minutes), with two notable exceptions (Carmustine and Thiotepa) having shorter, but still measured, breakthrough times. The FDA's acceptance of these results implies they meet the necessary criteria for the stated indications for use.
The remaining information requested in your prompt (sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth type, training set size, and training set ground truth) is not applicable or not present in this regulatory document, as it pertains to a physical medical device (surgical glove) and not an AI/ML software device.
§ 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).