# Hartalega Sdn Bhd

- Location (FDA's records): Kuala Lumpur, MY
- FDA decisions: 61 (1989–2020): 61 510(k) clearances
- Product codes: LZA (33), LYY (19), KGO (8), LZC (1)
- 510(k) review time since 2016: median 108 days, against 124 for FDA's reviews in the same codes and years (13 of 17 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Sanrea Healthcare Products Pvt, Ltd.: 1 (https://510kreport.com/company/sanrea-healthcare-products-pvt)
- Northstar Healthcare Holdings: 1 (https://510kreport.com/company/northstar-healthcare-holdings)
- Top Calibre Sdn Bhd: 1 (https://510kreport.com/company/top-calibre-sdn-bhd)
- Grand Work Plastic Products Co., Ltd.: 1 (https://510kreport.com/company/grand-work-plastic-products)
- Zhanjiang Jiali Glove Products Co., Ltd.: 1 (https://510kreport.com/company/zhanjiang-jiali-glove-products)
- Hartalega NGC Sdn. Bhd.: 1 (https://510kreport.com/company/hartalega-ngc-sdn-bhd)

## Its most-cited devices
- K201531: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (2020), cited by 2
- K091652: Nitrile Powder Fre Examination Gloves (Blue) Tested for Use with Chemothreapy Drugs (2009), cited by 2
- K132006: Sterile Nitrile Powder Free Examination Glove (Vblu), Sterle Nitrile Powder Free Examination Glove (Ablu) (2013), cited by 1
- K063046: Nitrile Powder Free Examination Gloves (Green) (2006), cited by 1

## Recent decisions
- K201748: Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs (Oct 2, 2020)
- K201531: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (Aug 5, 2020)
- K200897: Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) (Jun 1, 2020)
- K180645: Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) (Nov 16, 2018)
- K180786: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff (Nov 2, 2018)
- K173509: Biodegradable Nitrile Powder Free Examination Glove (Blue) (Aug 17, 2018)
- K180644: Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green (Aug 10, 2018)
- K180505: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) (Jun 14, 2018)

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