510(k) Report

FDA applicant

Sinetimed Latex Sdn Bhd

Taiping, Perak, MY2 decisions1999–19990 recalls

FDA records 2 decisions for Sinetimed Latex Sdn Bhd (Taiping, Perak, MY) in 1999: 2 510(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 Sinetimed Latex Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sinetimed Latex Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sinetimed Latex 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 Glove1decision
  • LZAPolymer Patient Examination Glove1decision

What has FDA decided for it lately?

  • K983828Nitrikleen- Nitrile Examination Glove Powder FreeSinetimed Latex Sdn Bhd · 1999
  • K983827Maxikleen-Latex Examination Glove Powder FreeSinetimed Latex Sdn Bhd · 1999

All 2 as Sinetimed Latex Sdn Bhd →