The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Maxter Powder Free Nitrile Medical Examination Gloves.
Device ID | K040176 |
510k Number | K040176 |
Device Name: | MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES |
Classification | Polymer Patient Examination Glove |
Applicant | MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor, MY 41050 |
Contact | Priscilla Wee |
Correspondent | Priscilla Wee MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor, 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 | 2004-01-26 |
Decision Date | 2004-02-24 |