Guangdong Kingfa Sci. & Tech.Co., Ltd.: FDA clearances and approvals
Guangdong Kingfa Sci. & Tech.Co., Ltd. has 14 FDA 510(k) clearances (first 2020, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time: 136 days. Since 2017 its median was 136 days, against 119 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 137 |
| 2021 | 3 | 100 |
| 2022 | 5 | 87 |
| 2023 | 3 | 197 |
| 2024 | 1 | 251 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Guangdong Kingfa Sci. & Tech.Co., Ltd.'s cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 6 | 6 |
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| LYZ | Vinyl Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (14)
Most recent Guangdong Kingfa Sci. & Tech.Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233723 | Medical surgical mask | FXX | 2024-07-29 | 251 |
| K231155 | Biodegradable Medical surgical mask | FXX | 2023-11-07 | 197 |
| 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 | 2023-04-27 | 295 |
| K230046 | Vinyl examination gloves | LYZ | 2023-03-25 | 78 |
| K222612 | Powder-Free Latex examination gloves | LYY | 2022-11-25 | 87 |
| 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 | 2022-10-07 | 29 |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color | LZA | 2022-09-24 | 87 |
| 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 | 2022-04-27 | 217 |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | FXX | 2022-04-05 | 161 |
| 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 | 2021-07-22 | 90 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Guangdong Kingfa Sci. & Tech.Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Guangdong Kingfa Sci. & Tech.Co., Ltd. have?
Guangdong Kingfa Sci. & Tech.Co., Ltd. has 14 FDA 510(k) clearances (first 2020, latest 2024), across 4 product codes in 1 review panel.
How long does FDA take to clear Guangdong Kingfa Sci. & Tech.Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Guangdong Kingfa Sci. & Tech.Co., Ltd.'s cleared 510(k)s is 136 days. Since 2017: 136 days, versus 119 days for all cleared 510(k)s in the same product codes.
What devices does Guangdong Kingfa Sci. & Tech.Co., Ltd. make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 6); LZA (Polymer Patient Examination Glove, 6); LYY (Latex Patient Examination Glove, 1).
Has Guangdong Kingfa Sci. & Tech.Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Guangdong Kingfa Sci. & Tech.Co., Ltd. Related entities may recall under other names.
Next steps
- See all 14 Guangdong Kingfa Sci. & Tech.Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Guangdong Kingfa Sci. & Tech.Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.