# Central Medicare Sdn Bhd

- Location (FDA's records): Teluk Intan, MY
- FDA decisions: 15 (2010–2023): 15 510(k) clearances
- Product codes: LZA (11), LZC (4)
- 510(k) review time since 2016: median 171 days, against 111 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 6 (5 its own); citations of its devices by later devices: 15 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hebei Hongsen Plastics Technology Co, Ltd.: 1 (https://510kreport.com/company/hebei-hongsen-plastics-technology)

## Firms that cite its devices most
- Ever Growth (Vietnam) Co., Ltd.: 2 (https://510kreport.com/company/ever-growth-vietnam)
- Jiangsu Nanfang Medical Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-nanfang-medical)
- Great Eco Glove Sdn. Bhd.: 1 (https://510kreport.com/company/great-eco-glove-sdn-bhd)
- Us Glove Supply: 1 (https://510kreport.com/company/us-glove-supply)
- Better Care Plastic Technology Co., Ltd.: 1 (https://510kreport.com/company/better-care-plastic-technology)
- Encompass Medical Supplies Inc Limited: 1 (https://510kreport.com/company/encompass-medical-supplies)
- Medline Industires, Inc.: 1 (https://510kreport.com/company/medline-industires)
- Halyard Health, Inc.: 1 (https://510kreport.com/company/halyard-health)

## Its most-cited devices
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2017), cited by 5
- K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), cited by 2
- K103734: Powder Free Nitrile Examination Gloves White Colored Non-Sterile (2011), cited by 2
- K093696: SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803 (2010), cited by 2
- K172642: Orange Non Sterile Powder Free Nitrile Examination Gloves (2017), cited by 2
- K203036: Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) (2021), cited by 1

## Recent decisions
- K230681: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl (Oct 2, 2023)
- K223752: Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl (Jul 24, 2023)
- K230875: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims (Jul 20, 2023)
- K230564: Green Non Sterile Powder Free Nitrile Examination Gloves (May 23, 2023)
- K213437: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims (Apr 11, 2022)
- K211022: Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. (Dec 22, 2021)
- K203036: Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) (May 7, 2021)
- K183149: Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim (Jul 4, 2019)

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