FDA applicant
Sumirubber Industries (Kedah) Sdn. Bhd.
FDA records 3 decisions for Sumirubber Industries (Kedah) Sdn. Bhd. (Sungai Petani, Kedah, MY) from 1989 to 1999: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and 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 Sumirubber Industries (Kedah) Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sumirubber Industries (Kedah) Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sumirubber Industries (Kedah) 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