The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs.
Device ID | K113100 |
510k Number | K113100 |
Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
Classification | Polymer Patient Examination Glove |
Applicant | MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, MY 41050 |
Contact | Yap P Geeh |
Correspondent | Yap P Geeh MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, MY 41050 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-19 |
Decision Date | 2012-02-06 |