FDA applicant
Guthrie Medicare Products (Melaka) Sdn Bhd
FDA records 12 decisions for Guthrie Medicare Products (Melaka) Sdn Bhd (Great Neck, NY) from 1991 to 2001: 12 510(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 Guthrie Medicare Products (Melaka) Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Guthrie Medicare Products (Melaka) Sdn Bhd since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Guthrie Medicare Products (Melaka) Sdn…’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