FDA applicant

Innolatex Sdn. Bhd

Shah Alam,Selangor Darul Ehsan, MY9 decisions2000–20060 recalls

FDA records 9 decisions for Innolatex Sdn. Bhd (Shah Alam,Selangor Darul Ehsan, MY) from 2000 to 2006: 9 510(k) clearances. Most are in product codes HIS (Condom) and LTZ (Condom With Nonoxynol-9). Its devices cite 2 predicates, 0 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 Innolatex Sdn. Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innolatex Sdn. Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Innolatex Sdn. Bhd’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 “Innolatex”

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

Innolatex (Thailand) Limited 1

Innolatex Sdn. Bhd

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 “Innolatex”