510(k) Report

FDA applicant

Five Star Rubber Products

Lama 58100 Kuala Lumpur, MY1 decision1989–19890 recalls

FDA records 1 decision for Five Star Rubber Products (Lama 58100 Kuala Lumpur, MY) in 1989: 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 Five Star Rubber Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Five Star Rubber Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Five Star Rubber Products by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Five Star Rubber Products’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Five”

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