510(k) Report

FDA applicant

Semperit Technische Produkte Gesellshaft

Apharetta, GA3 decisions1998–20020 recalls

FDA records 3 decisions for Semperit Technische Produkte Gesellshaft (Apharetta, GA) from 1998 to 2002: 3 510(k) clearances. All are in product code KGO (Surgeon'S Gloves). Its devices cite 2 predicates, 2 of them its own earlier devices. 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 Semperit Technische Produkte Gesellshaft’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Semperit Technische Produkte Gesellshaft since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Semperit Technische Produkte Gesellshaft 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?

  • KGOSurgeon'S Gloves3decisions

Who builds on its devices?

Later devices cite its devices 5 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K981096Sempermed Surgeons' Gloves - SupremeSemperit Technische Produkte Gesellshaft · 19984cite it
  • K013560Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft · 20021cites it

What has FDA decided for it lately?

  • K013560Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, and 9Semperit Technische Produkte Gesellshaft · 2002
  • K012819Sempermed Derma Plus, Sizes 5.5,6,6.5,7,7.5,8,8.5,9Semperit Technische Produkte Gesellshaft · 2001
  • K981096Sempermed Surgeons' Gloves - SupremeSemperit Technische Produkte Gesellshaft · 1998

All 3 as Semperit Technische Produkte Gesellshaft →

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 Industrial Products 2Semperit Technische Produkte Gesellchaft M.B.H. 1