510(k) Report

FDA applicant

Servicom Services Sdn Bhd

Janan Ampang, Kuala Lumpur, MY3 decisions1998–19980 recalls

FDA records 3 decisions for Servicom Services Sdn Bhd (Janan Ampang, Kuala Lumpur, MY) in 1998: 3 510(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 Servicom Services Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Servicom Services Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Servicom Services 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 Glove2decisions
  • LZAPolymer Patient Examination Glove1decision

What has FDA decided for it lately?

  • K981133Powdered Nitrile Examination GlovesServicom Services Sdn Bhd · 1998
  • K980611Powdered Latex Examination GlovesServicom Services Sdn Bhd · 1998
  • K974832Powderfree Latex Examination GlovesServicom Services Sdn Bhd · 1998

All 3 as Servicom Services Sdn Bhd →