# Hartalega Snd. Bhd.

- Location (FDA's records): Bandar Sri Damansara, MY
- FDA decisions: 2 (2012–2016): 2 510(k) clearances
- Product codes: LZA (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K160562: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (2016), cited by 1

## Recent decisions
- K160562: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs (Oct 13, 2016)
- K112976: Nitrile Powder Free Examination Gloves (White) with Colloidal Oatm (Feb 2, 2012)

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