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 |