FDA applicant
Lovytex Sdn Bhd
FDA records 3 decisions for Lovytex Sdn Bhd (Selangor, MY) from 1998 to 1999: 3 510(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 Lovytex Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Lovytex Sdn Bhd since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Lovytex Sdn Bhd’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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