FDA applicant

Ls Rubber Sdn Bhd

Alpharetta, GA3 decisions1999–20020 recalls

FDA records 3 decisions for Ls Rubber Sdn Bhd (Alpharetta, GA) from 1999 to 2002: 3 510(k) clearances. Most are in product codes HIS (Condom) and LTZ (Condom With Nonoxynol-9). Its devices cite 1 predicate, 1 of them its own earlier devices. 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Ls Rubber Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ls Rubber Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ls Rubber Sdn Bhd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Ls Rubber Sdn Bhd

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?