Search Results
Found 1 results
510(k) Data Aggregation
K Number
K182308Device Name
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
Manufacturer
Sri Trang Gloves (Thailand) Co., LTD.
Date Cleared
2019-05-30
(279 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves (Thailand) Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This device has been tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
The tested chemotherapy drugs are as follows:
Carmustine (BCNU) 3.3 mg/mL, 12.8 minutes breakthrough detection time
Cisplatin 1.0 mg/mL, No breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) 20 mg/mL, No breakthrough up to 240 minutes
Dacarbazine (DTIC) 10.0 mg/mL, No breakthrough up to 240 minutes
Doxorubicin Hydrochloride 2.0 mg/mL, No breakthrough up to 240 minutes
Etoposide (Toposar) 20.0 mg/mL, No breakthrough up to 240 minutes
Fluorouracil 50.0 mg/mL, No breakthrough up to 240 minutes
Methotrexate 25 mg/mL, No breakthrough up to 240 minutes
Paclitaxel (Taxol) 6.0 mg/mL, No breakthrough up to 240 minutes
Thiotepa 10.0 mg/mL, 4.5 minutes breakthrough detection time
Vincristine Sulfate 1.0 mg/mL, No breakthrough up to 240 minutes
CAUTION: Carmustine and Thiotepa have low breakthrough times of 12.8 and 4.5 minutes respectively.
Device Description
Non-sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs
Ask a Question
Page 1 of 1