# Purna Bina Sdn Bhd

- Location (FDA's records): Kluang, Johor D. Takzim, MY
- FDA decisions: 7 (1989–2014): 7 510(k) clearances
- Product codes: LYY (6), KGO (1)
- 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
- St. Marys Rubbers Pvt, Ltd.: 1 (https://510kreport.com/company/st-marys-rubbers-pvt)
- Beta Healthcare Products Pvt., Ltd.: 1 (https://510kreport.com/company/beta-healthcare-products-pvt)

## Its most-cited devices
- K130450: Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove (2014), cited by 2

## Recent decisions
- K130450: Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove (Sep 30, 2014)
- K083571: Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink Color (Aug 13, 2009)
- K041004: Illusion Powder Free-Polymer Coated Color Scented NR Latex Examination Gloves (Blue) (Jul 2, 2004)
- K022659: Illusion Powder Free-Ploymer Coated Color Scented NR Latex Examination Gloves (Blue) (Sep 25, 2002)
- K003904: Polymer Coated Powder Free Latex Examination Gloves (Jan 24, 2001)
- K994420: Powder Free Latex Examination Patient Gloves (Sep 18, 2000)
- K891507: Patient Examination Gloves (Latex) (Apr 6, 1989)

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