# Pt. Smartglove Indonesia

- Location (FDA's records): Tg Morawa-Deli Serdang Utara, ID
- FDA decisions: 12 (2003–2014): 12 510(k) clearances
- Product codes: LZA (9), LYY (3)
- 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
- K133699: Powder Free Green, Blue and Brown Polychloroprene Examination Gloves (Jul 18, 2014)
- K101630: Powder Free Nitrile Examination Gloves (6MIL), Tested for Use with Chemotherapy Drugs (Blue (Sep 7, 2010)
- K101293: Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue) (Jul 1, 2010)
- K092034: Powder Free Nitrile Examination Gloves, Black (Oct 19, 2009)
- K041848: Polymer Coat Powder Free Nitrile Examination Gloves, Green and White Color (Aug 20, 2004)
- K040792: Polymer Coated, Powder Free Latex Examination Glove (White) (Aug 12, 2004)
- K040791: Polymer Coat, Powder Free Nitrile Examination Glove (Blue) (Jun 3, 2004)
- K030284: Powder Free Nitrile Examination Gloves (Natural, Blue,Purple) (Mar 25, 2003)

Source page: https://510kreport.com/company/pt-smartglove-indonesia