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510(k) Data Aggregation
K Number
K182554Device Name
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
Manufacturer
Date Cleared
2019-03-22
(186 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**He Chuang Plastic **& Rubber Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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 proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with proposed device.
| Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------|------------------------|----------------------------------------|
| *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 |
| Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 |
| Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml(2,000 ppm) | >240 |
| Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 |
| Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 |
| Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 |
| Mitomycin C | 0.5 mg/ml(500 ppm) | >240 |
| Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 |
| *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 |
| Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
Device Description
The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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.
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