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 |