FDA applicant
Absolute Synthetic Technologies Malaysia Sdn. Bhd.
FDA records 3 decisions for Absolute Synthetic Technologies Malaysia Sdn. Bhd. (Kamunting, Taiping, Perak, MY) in 1997: 3 510(k) clearances. All are in product code 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 Absolute Synthetic Technologies Malaysia Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Absolute Synthetic Technologies Malaysia Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Absolute Synthetic Technologies…’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) ReportOther applicant names beginning “Absolute”
FDA records each applicant name separately; these may or may not be the same firm.