Guangdong Kingfa Sci.&tech.co.,Ltd.
Qingyuan Guangdong, CN
GUANGDONG KINGFA SCI.&TECH.CO.,LTD. appears in FDA device records in Qingyuan Guangdong, CN. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Guangdong Kingfa Sci.&tech.co.,Ltd. between 2020 and 2024. The busiest year on record is 2022, with 5. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233723 | Medical surgical mask | FXX | Substantially Equivalent | |
| K231155 | Biodegradable Medical surgical mask | FXX | Substantially Equivalent | |
| 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 | |
| K230046 | Vinyl examination gloves | LYZ | Substantially Equivalent | |
| K222612 | Powder-Free Latex examination gloves | LYY | Substantially Equivalent | |
| 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 | |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color | LZA | Substantially Equivalent | |
| 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 | |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | FXX | Substantially Equivalent | |
| K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K203593 | Patient Examination Gloves | LZA | Substantially Equivalent | |
| K202107 | Medical Protective Mask | FXX | Substantially Equivalent | |
| K201622 | Medical surgical mask | FXX | Substantially Equivalent | |
| K202139 | Medical surgical mask | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016785267 | 3016785267 | GUANGDONG KINGFA SCI.&TECH.CO.,LTD. | NO.28, Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China, Qingyuan Guangdong 511545 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain