Data / Medical devices / Cambodia / RMKH Glove (cambodia) Co., Ltd.
RMKH Glove (cambodia) Co., Ltd.: FDA-registered device maker in Bavet City Svay Rieng, Cambodia, 1 510(k) clearance
RMKH Glove (cambodia) Co., Ltd. is registered with the FDA (registration 3026062711) in Bavet City Svay Rieng, Cambodia. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026062711
- Address
- Manhattan Special Economic Zone Bavet Commune, Bavet City Svay Rieng, Cambodia, 120407
- Owner or operator
- RMKH GLOVE (CAMBODIA) CO., LTD. (10092138)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 9, 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 |
|---|---|---|---|---|---|---|
| January 4, 2023 | K222907 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Rmkh Glove (Cambodia) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
Updated January 4, 2023. 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.