Data / Medical devices / China / Shanghai Motex Healthcare Co., Ltd.
Shanghai Motex Healthcare Co., Ltd.: FDA-registered device maker in Shanghai, China, 9 510(k) clearances
Shanghai Motex Healthcare Co., Ltd. is registered with the FDA (registration 9615978) in Shanghai, China. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 23, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9615978
- FEI number
- 3003045222
- Address
- No. 369, Jiasong Zhong Road Huaxin, Qingpu, Shanghai, China, 201708
- Owner or operator
- SHANGHAI MOTEX HEALTHCARE CO., LTD. (9041164)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 18, 2007
- Registered through
- 2026
- Brand names listed
- Modern Healthcare, Motex Powder-Free Nitrile Surgical Gloves, Motex Powder-Free Polyisoprene Sterile Surgical Gloves, Motex Powdered Nitrile Surgical Gloves; Item 6010 White, 6010 Green, Nitrile Powder-Free Examination Gloves, ProBlue #7235, #7735, POWDER-FREE NITRILE EXAMINATION GLOVES, Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs, Shanghai Motex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2022 | K220155 | Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | Motex Healthcare (Anhui) Co., Ltd. | accessdata.fda.gov |
| June 4, 2014 | K123126 | MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) | KGO | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| May 21, 2014 | K132802 | MOTEX POWDERED NITRILE SURGICAL GLOVES | KGO | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| October 3, 2013 | K122557 | MOTEX POWDER-FREE NITRILE SURGICAL GLOVES | KGO | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| July 27, 2007 | K063757 | MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES | KGO | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| August 20, 2004 | K041276 | POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| May 2, 2003 | K030207 | NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 | LZA | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| December 2, 2002 | K020837 | MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE | LYY | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
| November 29, 2001 | K013261 | MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE | LZA | Substantially Equivalent | Shanghai Motex Healthcare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Surgeon'S Gloves
- All makers of Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
Updated May 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.