510(k) Report

FDA applicant

Top Calibre Sdn Bhd

Shah Alam, MY5 decisions2012–20140 recalls

FDA records 5 decisions for Top Calibre Sdn Bhd (Shah Alam, MY) from 2012 to 2014: 5 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). Its devices cite 5 predicates, 0 of them its own earlier devices. 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 Top Calibre Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2012: 32013: 12014: 1
2012high 3 (2012) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Top Calibre Sdn Bhd by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Top Calibre 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?

  • LYYLatex Patient Examination Glove4decisions
  • LZAPolymer Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K112612Powder Free Latex Patient Examination Glove, with Protein Content Labeling ClaimTop Calibre Sdn Bhd · 20121cites it

What has FDA decided for it lately?

  • K133949Powder Free Nitrile Patient Examination Glove,Blue and Orange Colored,Non-Sterile Tested for Use with…Top Calibre Sdn Bhd · 2014
  • K123819Multiple NameTop Calibre Sdn Bhd · 2013
  • K120692Latex Examination Gloves (Powder Free)Top Calibre Sdn Bhd · 2012
  • K120693Latex Examination Gloves (Powdered)Top Calibre Sdn Bhd · 2012
  • K112612Powder Free Latex Patient Examination Glove, with Protein Content Labeling ClaimTop Calibre Sdn Bhd · 2012

All 5 as Top Calibre Sdn Bhd →