# Ultrawin Sdn Bhd

- Location (FDA's records): Chemor, Perak, MY
- FDA decisions: 5 (1992–2009): 5 510(k) clearances
- Product codes: LYY (4), LZA (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (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
- Summit Glove, Inc.: 2 (https://510kreport.com/company/summit-glove)
- Koon Seng Sdn Bhd: 1 (https://510kreport.com/company/koon-seng-sdn-bhd)
- 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
- K090828: Non-Sterile, Powder Free Nitrile Examination Gloves (2009), cited by 5

## Recent decisions
- K090828: Non-Sterile, Powder Free Nitrile Examination Gloves (Jul 28, 2009)
- K072802: Single Use, Disposable, Blue Color, Powder Free Latex Patient Examination Glove (Feb 29, 2008)
- K992175: Extra-Care Latex Patient Examination Glove, Powder-Free, Polymer Coated (Sep 24, 1999)
- K983175: Extra-Care Powder-Free Examination Glove (Oct 13, 1998)
- K920059: Ultrasafe (Mar 11, 1992)

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