FDA applicant
Top Glove Vietnam Company Limited
FDA records 1 decision for Top Glove Vietnam Company Limited (Bau Bang, VN) in 2022: 1 510(k) clearance. All are in product code LYZ (Vinyl Patient Examination Glove). 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 Top Glove Vietnam Company Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2022high 1 (2022) · low 0 (2023)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Top Glove Vietnam Company Limited’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