The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Powder-free Nitrile Examination Gloves.
| Device ID | K041276 |
| 510k Number | K041276 |
| Device Name: | POWDER-FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHANGHAI MOTEX HEALTHCARE CO., LTD. 150J WEST PHILLIPS ROAD Greer, SC 29650 |
| Contact | Wunan Huang |
| Correspondent | Wunan Huang SHANGHAI MOTEX HEALTHCARE CO., LTD. 150J WEST PHILLIPS ROAD Greer, SC 29650 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-12 |
| Decision Date | 2004-08-20 |
| Summary: | summary |