510(k) Report

FDA applicant

Supermax Glove Manufacturing Sdn Bhd

Sungai Buloh, Selangor, MY6 decisions2000–20030 recalls

FDA records 6 decisions for Supermax Glove Manufacturing Sdn Bhd (Sungai Buloh, Selangor, MY) from 2000 to 2003: 6 510(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 Supermax Glove Manufacturing Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Supermax Glove Manufacturing Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Supermax Glove Manufacturing 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 Glove3decisions
  • KGOSurgeon'S Gloves2decisions
  • LZAPolymer Patient Examination Glove1decision

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.

  • K014230Sterile Powder Free Latex Surgeon Gloves with Protein Labeling Claim (50 Microgram or Less)Supermax Glove Manufacturing Sdn Bhd · 20021cites it

What has FDA decided for it lately?

  • K024083Green Powder Free Nitrile Medical Examination Gloves with Peppermint FlavorSupermax Glove Manufacturing Sdn Bhd · 2003
  • K014230Sterile Powder Free Latex Surgeon Gloves with Protein Labeling Claim (50 Microgram or Less)Supermax Glove Manufacturing Sdn Bhd · 2002
  • K013953Aurelia Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera and Ginseng with Protein…Supermax Glove Manufacturing Sdn Bhd · 2002
  • K013589Chlorinated Powder Free Latex Medical Examination Gloves with Aloe VeraSupermax Glove Manufacturing Sdn Bhd · 2002
  • K010198Sterile Powdered Latex Surgeon GlovesSupermax Glove Manufacturing Sdn Bhd · 2001
  • K000644Supergloves Sterile Powdered Latex Examination GlovesSupermax Glove Manufacturing Sdn Bhd · 2000

All 6 as Supermax Glove Manufacturing Sdn Bhd →

Other applicant names beginning “Supermax”

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

Supermax Sdn Bhd 9Supermax Plastic Products Co., Ltd. 3Supermax Healthcare Canada-Supermax Medical 2Supermax Latex Products Sdn. Bhd. 1