# Hartalega NGC Sdn. Bhd.

- Location (FDA's records): Sepang, MY
- FDA decisions: 31 (2014–2026): 31 510(k) clearances
- Product codes: LZA (24), KGO (5), OPC (1), LYY (1)
- 510(k) review time since 2016: median 108 days, against 118 for FDA's reviews in the same codes and years (13 of 22 faster)
- Predicates its devices cite: 10 (7 its own); citations of its devices by later devices: 14 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hartalega Sdn Bhd: 1 (https://510kreport.com/company/hartalega-sdn-bhd)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)

## Firms that cite its devices most
- Better Care Plastic Technology Co., Ltd.: 2 (https://510kreport.com/company/better-care-plastic-technology)
- Showa Best Glove, Inc.: 1 (https://510kreport.com/company/showa-best-glove)
- Syntex Healthcare Products Co., Ltd.: 1 (https://510kreport.com/company/syntex-healthcare-products)
- Grand Work Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/grand-work-plastic-products)
- Comfort Rubber Gloves Industries Sdn. Bhd.: 1 (https://510kreport.com/company/comfort-rubber-gloves-industries-sdn-bhd)
- Yty Industry (Manjung) Sdn Bhd: 1 (https://510kreport.com/company/yty-industry-manjung-sdn-bhd)

## Its most-cited devices
- K200581: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (2020), cited by 4
- K151997: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) (2016), cited by 2
- K200019: Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) (2020), cited by 2
- K162646: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) (2017), cited by 1
- K214074: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs (2022), cited by 1
- K223437: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (2023), cited by 1

## Recent decisions
- K260558: Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Jul 28, 2026)
- K254285: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue (Jul 20, 2026)
- K260867: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) (Jun 17, 2026)
- K250861: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) (Oct 23, 2025)
- K251319: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff (Jul 30, 2025)
- K243818: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (Jan 8, 2025)
- K223437: Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (May 17, 2023)
- K222225: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) (Nov 11, 2022)

Source page: https://510kreport.com/company/hartalega-ngc-sdn-bhd