FDA applicant
Shanghai Motex Healthcare Co., Ltd.
FDA records 8 decisions for Shanghai Motex Healthcare Co., Ltd. (Shanghai, CN) from 2001 to 2014: 8 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZA (Polymer Patient Examination Glove). Its devices cite 5 predicates, 1 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 Shanghai Motex Healthcare Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2014
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Shanghai Motex Healthcare 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