FDA applicant

Sempermed USA, Inc.

Palm Harbor, FL2 decisions2001–20010 recalls

FDA records 2 decisions for Sempermed USA, Inc. (Palm Harbor, FL) in 2001: 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 Sempermed USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sempermed USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sempermed USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sempermed”

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

Sempermed Glove Industries Sdn Bhd 1

Sempermed USA, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sempermed”