# Gmp Medicare Sdn. Bhd.

- Location (FDA's records): Klang, MY
- FDA decisions: 4 (2017–2026): 4 510(k) clearances
- Product codes: LZA (3), LZC (1)
- 510(k) review time since 2016: median 182 days, against 111 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K202003: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (2021), cited by 1

## Recent decisions
- K260312: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid (Sep 8, 2026)
- K250944: Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl (Apr 23, 2025)
- K202003: Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim (Feb 24, 2021)
- K163017: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Mar 22, 2017)

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