The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Motex Nitrile Examination Gloves Powder-free.
| Device ID | K013261 |
| 510k Number | K013261 |
| Device Name: | MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHANGHAI MOTEX HEALTHCARE CO., LTD. NO. 6318, FANG HUANG RD., HUAXIN Qingpu, Shanghai, CN |
| Contact | Tony T K Cheng |
| Correspondent | Tzu-wei Li CENTER FOR MEASUREMENT STANDARDS OF INDUSTRIAL BLDG. 16, 321 KUANG FU RD,SEC2 Hsinchu,, TW |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-10-01 |
| Decision Date | 2001-11-29 |
| Summary: | summary |