# Terang Nusa Sdn Bhd

- Location (FDA's records): Kota Bharu, Kelantan, MY
- FDA decisions: 26 (1989–2017): 26 510(k) clearances
- Product codes: KGO (15), LYY (6), LZA (5)
- 510(k) review time since 2016: median 105 days, against 171 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrp Asia Pacific Sdn. Bhd.: 1 (https://510kreport.com/company/wrp-asia-pacific-sdn-bhd)

## Firms that cite its devices most
- Shanghai Motex Healthcare Co., Ltd.: 1 (https://510kreport.com/company/shanghai-motex-healthcare)

## Its most-cited devices
- K000178: Nuzone Nitrile Surgical Gloves, Powdered, Green (2000), cited by 1
- K041436: Synthetic Surgical Glove-Powderfree Nuzone X2 (2004), cited by 1

## Recent decisions
- K170779: Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein (May 24, 2017)
- K161932: Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink (Nov 28, 2016)
- K153510: Powder Free Polychloroprene Examination Glove Green (Mar 21, 2016)
- K151392: Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less (Sep 18, 2015)
- K140355: Sensiflex Plus Sterile Latex Surgical Glove Powderfree with Protein Content Labeling Claim (Nov 6, 2014)
- K110698: Nuzone X2T Chemo, Polychloroprene Synthetic Tan Surgical Gloves Powder Free (Dec 7, 2011)
- K102230: Nugard Nitile Grey Color (Sep 10, 2010)
- K102119: Sur-G Glov and Maxitex (Aug 27, 2010)

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