510(k) Report

FDA applicant

Gx Corporation Sdn Bhd

Klang, Selangor, MY18 decisions2007–20210 recalls

FDA records 18 decisions for Gx Corporation Sdn Bhd (Klang, Selangor, MY) from 2007 to 2021: 18 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). 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 Gx Corporation Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 32008: 32009: 72010: 22011: 12019: 12021: 1
2007high 7 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gx Corporation 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?

  • LZAPolymer Patient Examination Glove15decisions
  • LZCMedical Glove, Specialty1decision
  • KGOSurgeon'S Gloves1decision
  • LYYLatex Patient Examination Glove1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K090412Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd · 20092cite it
  • K070097Powder Free Nitrile Examination Gloves, Peppermint Scented, Blue ColorGx Corporation Sdn Bhd · 20071cites it
  • K071119Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, White)Gx Corporation Sdn Bhd · 20071cites it

What has FDA decided for it lately?

  • K200915Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy DrugsGx Corporation Sdn Bhd · 2021
  • K183354Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl CitrateGx Corporation Sdn Bhd · 2019
  • K111328Powder Free Nitrile Examination GlovesGx Corporation Sdn Bhd · 2011
  • K102074Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, Blue (SG)Gx Corporation Sdn Bhd · 2010
  • K101828Powder Free Latex Examination Gloves (18 ML), Blue Tested for Use with Chemotherapy DrugsGx Corporation Sdn Bhd · 2010
  • K091851Sterile, Powder Free Nitrile Examination Glove, Blue, Tested for Use with Chemotherapy DrugsGx Corporation Sdn Bhd · 2009
  • K092072Powder Free Nitrile Examination Glove, Grape Scented, BlueGx Corporation Sdn Bhd · 2009
  • K091643Powder Free Latex Examination Gloves, Blue, Tested for Use with Chemotherapy DrugsGx Corporation Sdn Bhd · 2009

All 18 as Gx Corporation Sdn Bhd →