510(k) Report

FDA applicant

Concept Rubber Products Sdn Bhd

Seberang Perai, Penang, MY2 decisions1989–20000 recalls

FDA records 2 decisions for Concept Rubber Products Sdn Bhd (Seberang Perai, Penang, MY) from 1989 to 2000: 2 510(k) clearances. All are in product code LYY (Latex 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 Concept Rubber Products Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Concept Rubber Products Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Concept Rubber Products 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 Glove2decisions

What has FDA decided for it lately?

  • K003213Almatex Powder-Free Latex Exanination Gloves with Protien Labeling Claim 50 Micrograms or LessConcept Rubber Products Sdn Bhd · 2000
  • K891966Alamtex Patient Examination Gloves (Latex)Concept Rubber Products Sdn Bhd · 1989

All 2 as Concept Rubber Products Sdn Bhd →

Other applicant names beginning “Concept”

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

Concept, Inc. 84