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510(k) Data Aggregation
(232 days)
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection time are as follows :
| Chemotherapy Drugs & concentration | Average Breakthrough Detection Time |
|---|---|
| Carmustine (BCNU), 3300ppm | 60.2 |
| Cisplatin, 1000ppm | > 240 min |
| Cyclophosphamide (Cytoxan), 20,000 ppm | > 240 min |
| Dacarbazine (DTIC), 10,000 ppm | > 240 min |
| Doxorubicin Hydrochloride, 2000 ppm | > 240 min |
| Etoposide (Toposar), 20,000 ppm | > 240 min |
| Fluorouracil, 50,000 ppm | > 240 min |
| Ifosfamide, 50,000 ppm | > 240 min |
| Methotrexate, 25,000 ppm | > 240 min |
| Mitomycin C, 500 ppm | > 240 min |
| Mitoxantrone, 2000 ppm | > 240 min |
| Paclitaxel (Taxol), 6000 ppm | > 240 min |
| Thiothepa, 10,000 ppm | 105.6 |
| Vincristine Sulfate, 1000 ppm | > 240 min |
Please note that the following drugs have low permeation times: Carmustine - 60.2 minutes Thiothepa - 105.6 minutes
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This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Blue Nitrile Examination Gloves Tested With Chemotherapy Drugs". It primarily focuses on the regulatory approval process and includes a table of chemotherapy drug breakthrough times. This document does not describe the acceptance criteria of a device nor a study that proves the device meets those criteria in the context of an AI/medical imaging or diagnostic device.
The information requested in the prompt (sample size for test/training sets, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, etc.) is relevant for the evaluation of AI/diagnostic devices, not for examination gloves.
Therefore,Based on the provided document, the requested information about acceptance criteria and a study proving a device meets those criteria cannot be extracted. The document is a 510(k) premarket notification for "Powder Free Blue Nitrile Examination Gloves Tested With Chemotherapy Drugs" and pertains to regulatory clearance, not a study evaluating an AI/diagnostic device against specific performance acceptance criteria.
The only "performance" reported is related to the breakthrough detection time of chemotherapy drugs through the glove, which is a chemical resistance test, not a measure of diagnostic accuracy or AI performance.
Therefore, I cannot populate the table or answer the specific questions as they relate to a different type of device evaluation (e.g., AI in medical imaging) than what is presented in the document.
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