FDA applicant
Masju Sdn. Bhd.
FDA records 4 decisions for Masju Sdn. Bhd. (Sungai Petani, MY) from 1989 to 1999: 4 510(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 Masju Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Masju Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Masju 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