FDA applicant
Top Quality Glove Sdn. Bhd
FDA records 1 decision for Top Quality Glove Sdn. Bhd (Klang, MY) in 2017: 1 510(k) clearance. All are in product code 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 Top Quality Glove Sdn. Bhd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2017high 1 (2017) · low 0 (2018)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Top Quality Glove 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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