FDA applicant

Ansell Healthcare, Inc.

Dothan, AL3 decisions2000–20230 recalls

FDA records 3 decisions for Ansell Healthcare, Inc. (Dothan, AL) from 2000 to 2023: 3 510(k) clearances. Most are in product codes HIS (Condom) and KGO (Surgeon'S Gloves). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ansell Healthcare”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Ansell Healthcare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ansell Healthcare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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, Inc. 30 Ansell Perry 22 Ansell Intl. 4 Ansell Edmont Industrial, Inc. 2 Ansell Pacific, Inc. 2 Ansell Heathcare Products, LLC 1 Ansell Malaysia Sdn Bhd 1

Ansell Healthcare, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ansell”