510(k) Report

FDA applicant

Semperit Technische Produkte Gesellchaft M.B.H.

Wimpassing, AT1 decision2020–20200 recalls

FDA records 1 decision for Semperit Technische Produkte Gesellchaft M.B.H. (Wimpassing, AT) in 2020: 1 510(k) clearance. All are in product code 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 and plastic surgery panel, where it files most

How often FDA has decided Semperit Technische Produkte Gesellchaft M.B.H.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Semperit Technische Produkte Gesellchaft M.B.H. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Semperit”

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