FDA applicant

Ansell Malaysia Sdn Bhd

Melaka, MY1 decision1995–19950 recalls

FDA records 1 decision for Ansell Malaysia Sdn Bhd (Melaka, MY) in 1995: 1 510(k) clearance. All are in product code KGO (Surgeon'S Gloves). 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 and plastic surgery panel, where it files most

How often FDA has decided Ansell Malaysia Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ansell Malaysia Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ansell Malaysia Sdn Bhd’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 “Ansell”

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

Ansell Healthcare Products, LLC 36 Ansell, Inc. 30 Ansell Perry 22 Ansell Intl. 4 Ansell Healthcare, Inc. 3 Ansell Edmont Industrial, Inc. 2 Ansell Pacific, Inc. 2 Ansell Heathcare Products, LLC 1

Ansell Malaysia Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ansell”