FDA applicant

Nitritex (M) Sdn. Bhd.

Kuala Langat, Selangor De, MY3 decisions2008–20090 recalls

FDA records 3 decisions for Nitritex (M) Sdn. Bhd. (Kuala Langat, Selangor De, MY) from 2008 to 2009: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LZC (Medical Glove, Specialty). 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, general hospital panel, where it files most

How often FDA has decided Nitritex (M) Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Nitritex (M) Sdn. Bhd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nitritex (M) 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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Nitritex (M) Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?