FDA applicant
Formtex Medical Sdn. Bhd.
FDA records 3 decisions for Formtex Medical Sdn. Bhd. (Klang Pelabohan Klang, MY) from 1990 to 1993: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Formtex Medical Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Formtex Medical Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Formtex Medical 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