FDA applicant
Matang Mfg. Sdn. Bhd.
FDA records 8 decisions for Matang Mfg. Sdn. Bhd. (Jasin, Melaka, MY) from 1990 to 2012: 8 510(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 Matang Mfg. Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2012
2007high 2 (2012) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Matang Mfg. 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