510(k) Report

FDA applicant

Allied Rubber Industries Sdn. Bhd.

400000 Shah Alam.Malaysia, MY2 decisions1989–19900 recalls

FDA records 2 decisions for Allied Rubber Industries Sdn. Bhd. (400000 Shah Alam.Malaysia, MY) from 1989 to 1990: 2 510(k) clearances. Most are in product codes HIS (Condom) and 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Allied Rubber Industries Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Allied Rubber Industries 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 “Allied”

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