The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Motex Powder-free Nitrile Surgical Gloves.
| Device ID | K122557 |
| 510k Number | K122557 |
| Device Name: | MOTEX POWDER-FREE NITRILE SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 369, JIASONG ZHONG ROAD HUAXIN, QINGPU Shanghai, CN 201708 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 369, JIASONG ZHONG ROAD HUAXIN, QINGPU Shanghai, CN 201708 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-22 |
| Decision Date | 2013-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16930518060764 | K122557 | 000 |
| 16930518003648 | K122557 | 000 |
| 16930518003631 | K122557 | 000 |
| 00616784653914 | K122557 | 000 |
| 00616784653815 | K122557 | 000 |
| 00616784653716 | K122557 | 000 |
| 00616784653617 | K122557 | 000 |
| 00616784653518 | K122557 | 000 |
| 00616784653419 | K122557 | 000 |
| 00616784653310 | K122557 | 000 |
| 10814639023265 | K122557 | 000 |
| 10814639023241 | K122557 | 000 |
| 10814639023234 | K122557 | 000 |
| 10814639023210 | K122557 | 000 |
| 10814639023203 | K122557 | 000 |
| 16930518003662 | K122557 | 000 |
| 16930518003679 | K122557 | 000 |
| 16930518060757 | K122557 | 000 |
| 16930518060740 | K122557 | 000 |
| 16930518060733 | K122557 | 000 |
| 16930518060726 | K122557 | 000 |
| 00352410516177 | K122557 | 000 |
| 00352410516160 | K122557 | 000 |
| 00352410516153 | K122557 | 000 |
| 00352410516146 | K122557 | 000 |
| 00352410516139 | K122557 | 000 |
| 00352410516122 | K122557 | 000 |
| 16930518003723 | K122557 | 000 |
| 16930518003716 | K122557 | 000 |
| 16930518003709 | K122557 | 000 |
| 16930518003686 | K122557 | 000 |
| 10814639023180 | K122557 | 000 |