510(k) Report

FDA applicant

Metacure Surgical Gloves Sdn Bhd

Petaling Jaya, MY2 decisions2008–20080 recalls

FDA records 2 decisions for Metacure Surgical Gloves Sdn Bhd (Petaling Jaya, MY) in 2008: 2 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) 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 and plastic surgery panel, where it files most

How often FDA has decided Metacure Surgical Gloves Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2008: 2
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Metacure Surgical Gloves Sdn Bhd by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGOSurgeon'S Gloves1decision
  • LZCMedical Glove, Specialty1decision

What has FDA decided for it lately?

  • K073447Surgi GlovesMetacure Surgical Gloves Sdn Bhd · 2008
  • K072197Powder-Free Latex Examination Gloves - 18 Mils at Finger, Blue Color; 9 and 10 Mils at Finger, Natural ColorMetacure Surgical Gloves Sdn Bhd · 2008

All 2 as Metacure Surgical Gloves Sdn Bhd →