FDA applicant
Top Glove Medical (Thailand) Co., Ltd.
FDA records 3 decisions for Top Glove Medical (Thailand) Co., Ltd. (Songkhla, TH) from 2002 to 2023: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer 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 Medical (Thailand) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Top Glove Medical (Thailand) 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