The following data is part of a premarket notification filed by Shanghai Motex Healthcare Co., Ltd. with the FDA for Motex Latex Examination Gloves, Powder-free.
| Device ID | K020837 |
| 510k Number | K020837 |
| Device Name: | MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-14 |
| Decision Date | 2002-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819667020050 | K020837 | 000 |
| 10819667020040 | K020837 | 000 |
| 00819667020036 | K020837 | 000 |