The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Nitrile Powder-free Examination Gloves, Problue, #7235 7 #7735.
| Device ID | K030207 |
| 510k Number | K030207 |
| Device Name: | NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHANGHAI MOTEX HEALTHCARE CO., LTD. NO.6318, FANG HUANG RD, HUAXIN Qingpu, Shanghai, CN 201708 |
| Contact | Tony T.k. Cheng |
| Correspondent | Tony T.k. Cheng SHANGHAI MOTEX HEALTHCARE CO., LTD. NO.6318, FANG HUANG RD, HUAXIN Qingpu, Shanghai, CN 201708 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819667020029 | K030207 | 000 |
| 36971384150030 | K030207 | 000 |
| 36971384150047 | K030207 | 000 |
| 36971384150054 | K030207 | 000 |
| 36971384150016 | K030207 | 000 |
| 36930518036817 | K030207 | 000 |
| 36930518036824 | K030207 | 000 |
| 36930518036831 | K030207 | 000 |
| 36930518036848 | K030207 | 000 |
| 36930518036855 | K030207 | 000 |
| 06930518018140 | K030207 | 000 |
| 00819667020005 | K030207 | 000 |
| 00819667020012 | K030207 | 000 |
| 36971384150023 | K030207 | 000 |