510(k) Report

FDA applicant

Terang Nusa Sdn Bhd

Kota Bharu, Kelantan, MY26 decisions1989–20172 recalls

FDA records 26 decisions for Terang Nusa Sdn Bhd (Kota Bharu, Kelantan, MY) from 1989 to 2017: 26 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LYY (Latex Patient Examination Glove). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 171 for FDA’s reviews in the same codes and years. Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Terang Nusa Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 12010: 22011: 12014: 12015: 12016: 22017: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Terang Nusa Sdn Bhd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Terang Nusa Sdn Bhd’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KGOSurgeon'S Gloves15decisions
  • LYYLatex Patient Examination Glove6decisions
  • LZAPolymer Patient Examination Glove5decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 105 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 171 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K000178Nuzone Nitrile Surgical Gloves, Powdered, GreenTerang Nusa Sdn Bhd · 20001cites it
  • K041436Synthetic Surgical Glove-Powderfree Nuzone X2Terang Nusa Sdn Bhd · 20041cites it

What has FDA decided for it lately?

  • K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water…Terang Nusa Sdn Bhd · 2017
  • K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd · 2016
  • K153510Powder Free Polychloroprene Examination Glove GreenTerang Nusa Sdn Bhd · 2016
  • K151392Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with…Terang Nusa Sdn Bhd · 2015
  • K140355Sensiflex Plus Sterile Latex Surgical Glove Powderfree with Protein Content Labeling ClaimTerang Nusa Sdn Bhd · 2014
  • K110698Nuzone X2T Chemo, Polychloroprene Synthetic Tan Surgical Gloves Powder FreeTerang Nusa Sdn Bhd · 2011
  • K102230Nugard Nitile Grey ColorTerang Nusa Sdn Bhd · 2010
  • K102119Sur-G Glov and MaxitexTerang Nusa Sdn Bhd · 2010

All 26 as Terang Nusa Sdn Bhd →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K051563Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain…Dec 18, 2006
  • K982957Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4…May 23, 2006

Other applicant names beginning “Terang”

FDA records each applicant name separately; these may or may not be the same firm.

Terang Nusa Snd Bhd 1