FDA applicant

Nulatex Sdn. Bhd.

Kluang, Johor, MY3 decisions2007–20140 recalls

FDA records 3 decisions for Nulatex Sdn. Bhd. (Kluang, Johor, MY) from 2007 to 2014: 3 510(k) clearances. All are in product code HIS (Condom). 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 Nulatex Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Nulatex Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?