Data / Medical devices / China / Guangdong Kingfa Medical Sci.&tech. Co., Ltd.
Guangdong Kingfa Medical Sci.&tech. Co., Ltd.: FDA-registered device maker in Qingyuan Guangdong, China, 6 510(k) clearances
Guangdong Kingfa Medical Sci.&tech. Co., Ltd. is registered with the FDA (registration 3045062172) in Qingyuan Guangdong, China. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045062172
- Address
- NO. 36 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China, Qingyuan Guangdong, China, 511500
- Owner or operator
- GUANGDONG KINGFA MEDICAL SCI.&TECH. CO., LTD. (10095756)
- Roles
- Manufacturer
- First device listed
- April 24, 2026
- Registered through
- 2026
- Brand names listed
- Biodegradable Medical surgical mask:SPROUT-P11E(L1), Biodegradable Powder Free Nitrile Examination Gloves : BIO-G01, Biodegradable Powder Free Nitrile Examination Gloves : BIO-G02, Biodegradable Powder Free Nitrile Examination Gloves : BIO-G05, Medical Protective Mask (model: KF-A F02(N)), Medical Surgical Mask : KF-B P06, Medical Surgical Mask : KF-B P06(L3), Medical surgical mask (model: KF-B P05(L3)) colors: blue, pink, purple, white and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | 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 |
|---|---|---|---|---|---|---|
| November 7, 2023 | K231155 | Biodegradable Medical surgical mask | FXX | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| April 27, 2023 | K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color | LZA | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| April 5, 2022 | K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | FXX | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| January 15, 2021 | K202107 | Medical Protective Mask | FXX | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| November 24, 2020 | K201622 | Medical surgical mask | FXX | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
| November 20, 2020 | K202139 | Medical surgical mask | FXX | Substantially Equivalent | Guangdong Kingfa Sci. & Tech.Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 7, 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.