Terang Nusa Sdn Bhd
MalaysiaFDA applicant, unverified
- Devices
- 26
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Terang Nusa Sdn Bhd makes
Terang Nusa Sdn Bhd manufactures a range of single-use medical gloves, including powder-free latex examination gloves (with polymer coatings and low-protein claims), latex surgical gloves (powder-free and neuro-friendly variants), and synthetic alternatives such as nitrile, neoprene-polyisoprene, and polychloroprene gloves. Their portfolio also includes examination gloves for patient use, chemo-resistant surgical gloves, and procedure examination gloves. Some products feature additional coatings like aloe vera for enhanced comfort.
The company’s gloves are classified under Class I medical devices in the US and are listed in the FDA 510(k) registry. The products are intended for single-patient use in clinical, surgical, and examination settings. The manufacturer is based in the US.
Catalogue
Search and filter all 26 devicesFDA recalls
FDA recall records list 2 recalls initiated by Terang Nusa Sdn Bhd, the earliest on 2006-05-23 and the most recent on 2006-12-18. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 18 Dec 2006 Z-0365-2007 Unclassified (pre-2012) Terminated Some of the packages labeled as latex-free actually contain latex gloves.
- 23 May 2006 Z-1185-06 Unclassified (pre-2012) Terminated The sterile glove pouches may have an open seal at the bottom of the pouch.
Frequently asked questions
How many devices does Terang Nusa Sdn Bhd have in the registry?
The registry currently lists 26 devices for Terang Nusa Sdn Bhd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Terang Nusa Sdn Bhd's devices?
Among its 26 most recently registered devices, Terang Nusa Sdn Bhd has devices listed in FDA 510(k) (26 devices).
What risk classes do Terang Nusa Sdn Bhd's devices fall under?
Among its 26 most recently registered devices, the classes recorded for Terang Nusa Sdn Bhd's devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Terang Nusa Sdn Bhd?
FDA recall records list 2 recalls initiated by Terang Nusa Sdn Bhd, the most recent initiated on 18 Dec 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Terang Nusa Sdn Bhd in the registry?
The most recently registered devices listed for Terang Nusa Sdn Bhd include Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein, MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE, SUR-G GLOV AND MAXITEX and Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink.