FDA applicant
Pt. Eka Wira Asia
FDA records 3 decisions for Pt. Eka Wira Asia (Santa Fe Springs, CA) from 1994 to 1998: 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 Pt. Eka Wira Asia’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pt. Eka Wira Asia since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pt. Eka Wira Asia’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