The following data is part of a premarket notification filed by Maxter Glove Manufacturing Sdn Bhd with the FDA for Maxter Sterile Powder Free Surgical Gloves.
Device ID | K032501 |
510k Number | K032501 |
Device Name: | MAXTER STERILE POWDER FREE SURGICAL GLOVES |
Classification | Surgeon's Gloves |
Applicant | MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor, MY 41050 |
Contact | Stanley Thai |
Correspondent | Stanley Thai MAXTER GLOVE MANUFACTURING SDN BHD LOT 6070, JALAN HAJI ABDUL MANAN, 6TH MILES OFF JALAN Meru, Klang, Selangor, MY 41050 |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-13 |
Decision Date | 2003-10-17 |