Data / Medical devices / China / Guangdong Kingfa Sci.&tech.co.,ltd.
Guangdong Kingfa Sci.&tech.co.,ltd.: FDA-registered device maker in Qingyuan Guangdong, China, 2 510(k) clearances
Guangdong Kingfa Sci.&tech.co.,ltd. is registered with the FDA (registration 3016785267) in Qingyuan Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016785267
- Address
- NO.28, Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China, Qingyuan Guangdong, China, 511545
- Owner or operator
- GUANGDONG KINGFA SCI.&TECH.CO.,LTD. (10065634)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 20, 2021
- Registered through
- 2026
- Brand names listed
- Powder Free Nitrile Examination Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 7, 2022 | K222714 | 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 |
| March 19, 2021 | K203593 | Patient Examination Gloves | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
Updated October 7, 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.