510(k) Report

FDA applicant

Purna Bina Sdn Bhd

Kluang, Johor D. Takzim, MY7 decisions1989–20140 recalls

FDA records 7 decisions for Purna Bina Sdn Bhd (Kluang, Johor D. Takzim, MY) from 1989 to 2014: 7 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). No recall is 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 hospital panel, where it files most

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

FDA decisions per year

1in 2014

2009: 12014: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LYYLatex Patient Examination Glove6decisions
  • KGOSurgeon'S Gloves1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K130450Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical GlovePurna Bina Sdn Bhd · 20142cite it

What has FDA decided for it lately?

  • K130450Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical GlovePurna Bina Sdn Bhd · 2014
  • K083571Illusion Powder Free Exam Gloves, Natural Color with Vanilla Scent, Orange Color with Citric Scent and Pink…Purna Bina Sdn Bhd · 2009
  • K041004Illusion Powder Free-Polymer Coated Color Scented NR Latex Examination Gloves (Blue)Purna Bina Sdn Bhd · 2004
  • K022659Illusion Powder Free-Ploymer Coated Color Scented NR Latex Examination Gloves (Blue)Purna Bina Sdn Bhd · 2002
  • K003904Polymer Coated Powder Free Latex Examination GlovesPurna Bina Sdn Bhd · 2001
  • K994420Powder Free Latex Examination Patient GlovesPurna Bina Sdn Bhd · 2000
  • K891507Patient Examination Gloves (Latex)Purna Bina Sdn Bhd · 1989

All 7 as Purna Bina Sdn Bhd →