FDA applicant

Ansell, Inc.

Dothan, AL30 decisions1980–19990 recalls

FDA records 30 decisions for Ansell, Inc. (Dothan, AL) from 1980 to 1999: 30 510(k) clearances. Most are in product codes HIS (Condom) and 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 Ansell, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ansell, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ansell, 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 “Ansell”

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

Ansell Healthcare Products, LLC 36 Ansell Perry 22 Ansell Intl. 4 Ansell Healthcare, Inc. 3 Ansell Edmont Industrial, Inc. 2 Ansell Pacific, Inc. 2 Ansell Heathcare Products, LLC 1 Ansell Malaysia Sdn Bhd 1

Ansell, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ansell”