FDA applicant
Pantai Utama Sdn. Bhd.
FDA records 2 decisions for Pantai Utama Sdn. Bhd. (Seri Kembangan, Selangor, MY) in 1996: 2 510(k) clearances. All are in product code LYY (Latex 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 Pantai Utama Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pantai Utama Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pantai Utama 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