510(k) Report

FDA applicant

Ansell Heathcare Products, LLC

Dothan, AL1 decision2012–20121 recall

FDA records 1 decision for Ansell Heathcare Products, LLC (Dothan, AL) in 2012: 1 510(k) clearance. All are in product code HIS (Condom). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Ansell Heathcare Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2012high 1 (2013) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Ansell Heathcare Products, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HISCondom1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 20121cites it

What has FDA decided for it lately?

  • K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC · 20121 recall

The one decision as Ansell Heathcare Products, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K120394LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare…Jan 14, 2013Class II

Other applicant names beginning “Ansell”

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

Ansell Healthcare Products, LLC 36Ansell, Inc. 30Ansell Perry 22Ansell Intl. 4Ansell Healthcare, Inc. 3Ansell Edmont Industrial, Inc. 2Ansell Pacific, Inc. 2Ansell Malaysia Sdn Bhd 1