FDA applicant
Guangdong Kingfa Sci. & Tech.Co., Ltd.
FDA records 14 decisions for Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN) from 2020 to 2024: 14 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 161 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Guangdong Kingfa Sci. & Tech.Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Guangdong Kingfa Sci. & Tech.Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report