Search Results
Found 2 results
510(k) Data Aggregation
K Number
K160562Device Name
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Manufacturer
HARTALEGA SND. BHD.
Date Cleared
2016-10-13
(227 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SND. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) is as below:
| Carmustine (3.3 mg/ml) | 10.1 minutes |
|---------------------------------------|--------------|
| Cisplatin (1.0 mg/ml) | >240 minutes |
| Cyclophosphamide (20 mg/ml) | >240 minutes |
| Dacarbazine (10.1 mg/ml) | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes |
| Etoposide (20.0 mg/ml) | >240 minutes |
| Fluorouracil (50.0 mg/ml) | >240 minutes |
| Methotrexate (25 mg/ml) | >240 minutes |
| Mitomycin C (0.5 mg/ml) | >240 minutes |
| Paclitaxel (6.0 mg/ml) | >240 minutes |
| Thiotepa (10.0 mg/ml) | 30.4 minutes |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes |
Device Description
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
Ask a Question
K Number
K112976Device Name
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
Manufacturer
HARTALEGA SND. BHD.
Date Cleared
2012-02-02
(119 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HARTALEGA SND. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1