Data / Medical devices / China / Guangdong Vyimed Co., Ltd.
Guangdong Vyimed Co., Ltd.: FDA-registered device maker in Qingyuan Guangdong, China, 2 510(k) clearances
Guangdong Vyimed Co., Ltd. is registered with the FDA (registration 3030671502) in Qingyuan Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030671502
- Address
- Building A605, Delong Industrial Avenue, Qingyuan City, Guangdong Province, China, Qingyuan Guangdong, China, 511500
- Owner or operator
- Guangdong VyiMed Co., Ltd. (10090040)
- Roles
- Manufacturer
- First device listed
- April 18, 2024
- Registered through
- 2026
- Brand names listed
- Nitrile Examination Glove: KG-1104; Nitrile Examination Glove: KG-1303; Nitrile Examination Glove: KG-1106, Powder Free Nitrile Examination Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| September 24, 2022 | K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| April 27, 2022 | K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated September 24, 2022. 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.