510(k) Report

FDA applicant

Sj Medical Products (M) Sdn Bhd

Selangor Darul Ehsan, MY5 decisions1994–19970 recalls

FDA records 5 decisions for Sj Medical Products (M) Sdn Bhd (Selangor Darul Ehsan, MY) from 1994 to 1997: 5 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). 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 Sj Medical Products (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sj Medical Products (M) Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sj Medical Products (M) 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
  • LZAPolymer Patient Examination Glove2decisions

What has FDA decided for it lately?

  • K971666Smart - Fit, Prepowdered Nitrile Examination GlovesSj Medical Products (M) Sdn Bhd · 1997
  • K971665Smart - Fit, Powderfree Nitrile Examination GlovesSj Medical Products (M) Sdn Bhd · 1997
  • K971403Smart - Glove Powder Free Latex Examination GloveSj Medical Products (M) Sdn Bhd · 1997
  • K941754Powder Free Latex Exmination GlovesSj Medical Products (M) Sdn Bhd · 1994
  • K932332Patient Examination Glove - PowderedSj Medical Products (M) Sdn Bhd · 1994

All 5 as Sj Medical Products (M) Sdn Bhd →