FDA applicant
Suzhou Colour-Way New Material Co., Ltd.
FDA records 3 decisions for Suzhou Colour-Way New Material Co., Ltd. (Suzhou, CN) from 2022 to 2024: 3 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and HIS (Condom). Its devices cite 1 predicate, 0 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 Suzhou Colour-Way New Material 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 2022.
Planning a device like Suzhou Colour-Way New Material 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