# Pt Mahakarya Inti Buana

- Location (FDA's records): Morawa, Sumut, ID
- FDA decisions: 9 (2005–2011): 9 510(k) clearances
- Product codes: LYY (5), LZA (4)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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
- Sunmax Vietnam Co., Ltd.: 1 (https://510kreport.com/company/sunmax-vietnam)
- Chienmax Vietnam Co., Ltd.: 1 (https://510kreport.com/company/chienmax-vietnam)

## Its most-cited devices
- K090464: Black Nitrile Examination Gloves, Powder Free, Non Sterile (2009), cited by 2

## Recent decisions
- K111300: Senstouch Nitrile Examination Gloves, Powder Free, Non Sterile (Green, Orange, Violet and White) (Aug 12, 2011)
- K090464: Black Nitrile Examination Gloves, Powder Free, Non Sterile (Apr 23, 2009)
- K063581: Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non Sterile (Mar 15, 2007)
- K062313: Senstouch High Risk Latex Examination Gloves, Powder Free, Non Sterile (Nov 30, 2006)
- K061233: Senstouch Powder Free Examination Gloves, Non Sterile (Nov 3, 2006)
- K053305: Senstouch Powdered Examination Gloves, Non Sterile (Jun 2, 2006)
- K053366: Nitrile Examination Gloves, Powdered, Non Sterile (Mar 30, 2006)
- K053657: Powder Free Nitrile Examination Gloves, Non-Sterile (Feb 13, 2006)

Source page: https://510kreport.com/company/pt-mahakarya-inti-buana