510(k) Report

FDA applicant

United Lion Rubber Industries Sdn. Bhd.

Shah Alam, MY3 decisions1989–19900 recalls

FDA records 3 decisions for United Lion Rubber Industries Sdn. Bhd. (Shah Alam, MY) from 1989 to 1990: 3 510(k) clearances. 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 United Lion Rubber Industries Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for United Lion Rubber Industries Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like United Lion 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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