Data / Medical devices / Thailand / Mercator Medical (thailand) Ltd.
Mercator Medical (thailand) Ltd.: FDA-registered device maker in Ratthaphum Songkhla, Thailand, 6 510(k) clearances
Mercator Medical (thailand) Ltd. is registered with the FDA (registration 3004577220) in Ratthaphum Songkhla, Thailand. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 17, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004577220
- Address
- 88/8, 88/9, 88/10 Moo 12, Tambon Kampaengphet, Ratthaphum Songkhla, Thailand, 90180
- Owner or operator
- Mercator Medical (Thailand) Ltd. (9063727)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 24, 2018
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 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 |
|---|---|---|---|---|---|---|
| November 17, 2025 | 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 | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| February 21, 2022 | K213548 | Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| June 6, 2020 | K200967 | mCare(R) Powder Free Nitrile Orange Examination Gloves | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| December 31, 2019 | K192444 | mCare® Powder Free Nitrile Black Examination Glove | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| December 2, 2019 | K190876 | mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
| April 13, 2018 | K172930 | mCare Powder-free Blue Nitrile Examination Gloves | LZA | Substantially Equivalent | Mercator Medical (Thailand), Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
Updated November 17, 2025. 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.