Mercator Medical (Thailand), Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mercator Medical (Thailand), Ltd.” (first 2015, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 200 days. Since 2017 the median was 158 days, against 114 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 1 | 330 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 200 |
| 2019 | 2 | 179 |
| 2020 | 1 | 57 |
| 2021 | 0 | — |
| 2022 | 1 | 105 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 217 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mercator Medical (Thailand), Ltd. took a median 158 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Mercator Medical (Thailand), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2025-11-17 | 217 |
| K213548 | Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy | LZA | 2022-02-21 | 105 |
| K200967 | mCare(R) Powder Free Nitrile Orange Examination Gloves | LZA | 2020-06-06 | 57 |
| K192444 | mCare® Powder Free Nitrile Black Examination Glove | LZA | 2019-12-31 | 116 |
| K190876 | mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed | LZA | 2019-12-02 | 242 |
| K172930 | mCare Powder-free Blue Nitrile Examination Gloves | LZA | 2018-04-13 | 200 |
| K141042 | MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES | LYY | 2015-03-19 | 330 |
Recalls
openFDA lists no recalls under a recalling firm named Mercator Medical (Thailand), 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.
- Mercator Medsystems, Inc. (5 510(k)s)
- Mercator Healthcare , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mercator Medical (Thailand), Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Mercator Medical (Thailand), Ltd.” (first 2015, latest 2025), across 2 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 Mercator Medical (Thailand), Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mercator Medical (Thailand), Ltd. is 200 days. Since 2017: 158 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mercator Medical (Thailand), Ltd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 6); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 7 Mercator Medical (Thailand), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Mercator Medical (Thailand), 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.