# Bright Element Sdn Bhd

- Location (FDA's records): Subang Jaya,  Selangor, MY
- FDA decisions: 4 (2006–2007): 4 510(k) clearances
- Product codes: LZA (2), LYY (2)
- 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
- K063776: Able Glove Latex Powdered Examination Gloves (Mar 2, 2007)
- K063777: Able Glove Nitrile Blue Powder Free Examination Glove (Feb 23, 2007)
- K061074: Able Glove, Nitrile Blue Powdered Examination Gloves (May 24, 2006)
- K061078: Bright Element SND BHD Latex Powder Free Examination Gloves (May 19, 2006)

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