FDA applicant
Quality Gallant Sdn. Bhd.
FDA records 4 decisions for Quality Gallant Sdn. Bhd. (Taiping, Perak, MY) from 2007 to 2010: 4 510(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 Quality Gallant Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2010
2007high 2 (2007) · low 0 (2009)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Quality Gallant 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