Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangdong Kingfa Sci. & Tech.Co., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
251 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233723 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2024-07-29 | 251 | 0 |
| K231155 | Biodegradable Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-11-07 | 197 | 0 |
| K221983 | Biodegradable Powder Free Nitrile Examination Glove, Blue Co | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-04-27 | 295 | 0 |
| K230046 | Vinyl examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2023-03-25 | 78 | 0 |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-11-25 | 87 | 0 |
| K222714 | Nitrile Patient Examination Gloves Blue Tested For Use With | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-10-07 | 29 | 0 |
| K221887 | Nitrile Examination Glove, Pink Color; Nitrile Examination G | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-09-24 | 87 | 0 |
| K213040 | Nitrile Patient Examination Gloves Blue Tested For Use With | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-04-27 | 217 | 0 |
| K213450 | Medical surgical mask (Black mask, Level 1 and Level 3) | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2022-04-05 | 161 | 0 |
| K211220 | Nitrile Patient Examination Gloves Blue Tested For Use With | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-07-22 | 90 | 0 |
| K203593 | Patient Examination Gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-03-19 | 100 | 0 |
| K202107 | Medical Protective Mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2021-01-15 | 170 | 0 |
| K201622 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-24 | 162 | 0 |
| K202139 | Medical surgical mask | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 2020-11-20 | 112 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda