The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Motex Powder-free Surgical Gloves And Lightly Powdered Surgical Gloves.
| Device ID | K063757 |
| 510k Number | K063757 |
| Device Name: | MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES |
| Classification | Surgeon's Gloves |
| Applicant | SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814639023418 | K063757 | 000 |
| 16930518030736 | K063757 | 000 |
| 16930518030729 | K063757 | 000 |
| 36971384150931 | K063757 | 000 |
| 36971384150924 | K063757 | 000 |
| 36971384150917 | K063757 | 000 |
| 36971384150900 | K063757 | 000 |
| 36971384150894 | K063757 | 000 |
| 36971384150887 | K063757 | 000 |
| 36971384150870 | K063757 | 000 |
| 36971384150863 | K063757 | 000 |
| 36971384150856 | K063757 | 000 |
| 36971384150849 | K063757 | 000 |
| 16930518032181 | K063757 | 000 |
| 16930518032174 | K063757 | 000 |
| 16930518030743 | K063757 | 000 |
| 16930518030750 | K063757 | 000 |
| 16930518030767 | K063757 | 000 |
| 10814639023401 | K063757 | 000 |
| 10814639023395 | K063757 | 000 |
| 10814639023388 | K063757 | 000 |
| 10814639023371 | K063757 | 000 |
| 16930518032167 | K063757 | 000 |
| 16930518032150 | K063757 | 000 |
| 16930518032143 | K063757 | 000 |
| 16930518032136 | K063757 | 000 |
| 16930518032129 | K063757 | 000 |
| 16930518031764 | K063757 | 000 |
| 16930518031757 | K063757 | 000 |
| 16930518031740 | K063757 | 000 |
| 16930518031733 | K063757 | 000 |
| 16930518031726 | K063757 | 000 |
| 06930518032115 | K063757 | 000 |