Shanghai Motex Healthcare Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Shanghai Motex Healthcare Co., Ltd.” (first 2001, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 238 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 407 |
| 2014 | 2 | 432 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Shanghai Motex Healthcare Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123126 | MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) | KGO | 2014-06-04 | 608 |
| K132802 | MOTEX POWDERED NITRILE SURGICAL GLOVES | KGO | 2014-05-21 | 257 |
| K122557 | MOTEX POWDER-FREE NITRILE SURGICAL GLOVES | KGO | 2013-10-03 | 407 |
| K063757 | MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES | KGO | 2007-07-27 | 220 |
| K041276 | POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | 2004-08-20 | 100 |
| K030207 | NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 | LZA | 2003-05-02 | 101 |
| K020837 | MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE | LYY | 2002-12-02 | 263 |
| K013261 | MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE | LZA | 2001-11-29 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Shanghai Motex Healthcare Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai Motex Healthcare Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Shanghai Motex Healthcare Co., Ltd.” (first 2001, latest 2014), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shanghai Motex Healthcare Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai Motex Healthcare Co., Ltd. is 238 days.
Which FDA product codes appear under Shanghai Motex Healthcare Co., Ltd.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 4); LZA (Polymer Patient Examination Glove, 3); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 8 Shanghai Motex Healthcare Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Shanghai Motex Healthcare Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.