FDA applicant
Tg Medical Sdn. Bhd.
FDA records 9 decisions for Tg Medical Sdn. Bhd. (Klang, Selangor D.E., MY) from 1994 to 2017: 9 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tg Medical Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2007high 1 (2012) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tg Medical 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