FDA applicant

Multisafe Sdn. Bhd.

35500 Bidor, Perak Darul Ridzu, MY8 decisions2000–20180 recalls

FDA records 8 decisions for Multisafe Sdn. Bhd. (35500 Bidor, Perak Darul Ridzu, MY) from 2000 to 2018: 8 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer Patient Examination Glove). 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2018

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Multisafe Sdn. Bhd.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?