FDA applicant
Ug Global Resources Sdn. Bhd.
FDA records 5 decisions for Ug Global Resources Sdn. Bhd. (Seremban, MY) from 2012 to 2024: 5 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 297 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Ug Global Resources Sdn. Bhd.’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 2012.
Planning a device like Ug Global Resources Sdn. Bhd.’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