FDA applicant
Ultrawin Sdn Bhd
FDA records 5 decisions for Ultrawin Sdn Bhd (Chemor, Perak, MY) from 1992 to 2009: 5 510(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 Ultrawin Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2007high 1 (2008) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ultrawin 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