Data / Medical devices / Cambodia / Medtecs Msez Corp., Ltd.
Medtecs Msez Corp., Ltd.: FDA-registered device maker in Krong Bavet Svay Rieng, Cambodia, 5 510(k) clearances
Medtecs Msez Corp., Ltd. is registered with the FDA (registration 3017114229) in Krong Bavet Svay Rieng, Cambodia. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 9, 2024. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017114229
- Address
- Manhattan SEZ, National Road #1, Sangkat Baty, Krong Bavet Svay Rieng, Cambodia, 120407
- Owner or operator
- MEDTECS MSEZ CORP., LTD. (10092237)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 16, 2024
- Registered through
- 2026
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 |
|---|---|---|---|---|---|---|
| February 9, 2024 | K240072 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Luliang Hongruida Health Protection Technology Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K213440 | Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Luliang Hongruida Health Protection Technology Co., Ltd. | accessdata.fda.gov |
| November 30, 2018 | K182600 | Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Better Care Plastic Technology Co., Ltd. | accessdata.fda.gov |
| January 17, 2013 | K122408 | POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) | LZA | Substantially Equivalent | Hongye Plastic Products Co., Ltd. | accessdata.fda.gov |
| May 15, 2007 | K070861 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hong Xin Rubber Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated February 9, 2024. 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.