# Ksg Medicare Sdn. Bhd.

- Location (FDA's records): Tangkak, MY
- FDA decisions: 3 (2022–2024): 3 510(k) clearances
- Product codes: LZA (3)
- 510(k) review time since 2016: median 75 days, against 111 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K241745: Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) (Sep 11, 2024)
- K220209: Powder Free Nitrile Examination Glove, Non-sterile (Blue) (Apr 11, 2022)
- K220215: Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) (Mar 26, 2022)

Source page: https://510kreport.com/company/ksg-medicare-sdn-bhd