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 |