The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Motex Powdered Nitrile Surgical Gloves.
| Device ID | K132802 |
| 510k Number | K132802 |
| Device Name: | MOTEX POWDERED 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 | 2013-09-06 |
| Decision Date | 2014-05-21 |
| Summary: | summary |