FDA applicant

Latexx Manufacturing Sdn.Bhd.

Hackensack, NJ10 decisions2002–20120 recalls

FDA records 10 decisions for Latexx Manufacturing Sdn.Bhd. (Hackensack, NJ) from 2002 to 2012: 10 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2012

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Latexx Manufacturing 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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Other applicant names beginning “Latexx”

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

Latexx Partners Bhd. 7 Latexx Partners, Inc. 1

Latexx Manufacturing 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 “Latexx”