# Pt. Intan Hevea Industry

- Location (FDA's records): Medan - Indonesia, ID
- FDA decisions: 2 (1989–2011): 2 510(k) clearances
- Product codes: LYY (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K894480: Patient Examination Gloves (1989), cited by 1

## Recent decisions
- K111923: Skin Guard, Powder Free Latex Examination Gloves, Non-Sterile (Nov 4, 2011)
- K894480: Patient Examination Gloves (Sep 15, 1989)

Source page: https://510kreport.com/company/pt-intan-hevea-industry