FDA applicant
Chienmax Vietnam Co., Ltd.
FDA records 1 decision for Chienmax Vietnam Co., Ltd. (Great Neck, NY) in 2011: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 3 predicates, 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 Chienmax Vietnam Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Chienmax Vietnam 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