FDA applicant

Sama Kejuruteraan Sdn.Bhd.

Selangor D.E., MY1 decision1999–19990 recalls

FDA records 1 decision for Sama Kejuruteraan Sdn.Bhd. (Selangor D.E., MY) in 1999: 1 510(k) clearance. All are in product code LYY (Latex Patient Examination Glove). 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 Sama Kejuruteraan Sdn.Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sama Kejuruteraan Sdn.Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sama Kejuruteraan 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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Sama Kejuruteraan Sdn.Bhd.

Which product codes does it file in?

What has FDA decided for it lately?