# Hartalega Sdb. Bhd.

- Location (FDA's records): Bandar Sri Damansara, MY
- FDA decisions: 4 (2014–2017): 4 510(k) clearances
- Product codes: LZA (2), KGO (1), LYY (1)
- 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
- K162924: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) (Jan 24, 2017)
- K160928: Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) (Dec 20, 2016)
- K142805: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) (Dec 18, 2014)
- K142270: Latex Powdered Examination Gloves with Protein Labeling Claim of 200 Microgram or Less Per Gram of Glove (Nov 25, 2014)

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