510(k) Report

FDA applicant

Prestige Manufacturing Snd Bhd

58200 Kuala Lumpur Malays, MY2 decisions1989–19910 recalls

FDA records 2 decisions for Prestige Manufacturing Snd Bhd (58200 Kuala Lumpur Malays, MY) from 1989 to 1991: 2 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LYL (Accessories, Solution, Ultrasonic Cleaners For…). 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 Prestige Manufacturing Snd Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prestige Manufacturing Snd Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Prestige Manufacturing Snd 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 “Prestige”

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