510(k) Report

FDA applicant

Semperit Industrial Products

Montvale, NJ2 decisions1990–19900 recalls

FDA records 2 decisions for Semperit Industrial Products (Montvale, NJ) in 1990: 2 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). 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 Semperit Industrial Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Semperit Industrial Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Semperit Industrial Products 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
  • KGOSurgeon'S Gloves1decision

What has FDA decided for it lately?

  • K900587Sempermed Surgeon's GlovesSemperit Industrial Products · 1990
  • K896428Sempermed Latex Examination GlovesSemperit Industrial Products · 1990

All 2 as Semperit Industrial Products →

Other applicant names beginning “Semperit”

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

Semperit Investments Asia Pte, Ltd. 4Semperit Technische Produkte Gesellshaft 3Semperit Technische Produkte Gesellchaft M.B.H. 1