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510(k) Data Aggregation
K Number
K223748Device Name
Nitrile Exam Gloves (Chemotherapy Drug Tested)
Manufacturer
Date Cleared
2023-01-13
(30 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
US Medical Glove Company LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powder-free, nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Drug Name | Concentration Tested | Minimum Breakthrough Detection Time (Minutes) |
|----------------------------|-------------------------|-----------------------------------------------|
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | No breakthrough up to 240 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 240 |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | No breakthrough up to 14.3 * |
| Thiotepa | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 48.2 * |
*Please note that Carmustine and Thiotepa have low permeation times. Do not use with Carmustine and/or Thiotepa.
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