FDA applicant

Kossan International Sdn Bhd3

Klang, MY1 decision2023–20230 recalls

FDA records 1 decision for Kossan International Sdn Bhd3 (Klang, MY) in 2023: 1 510(k) clearance. All are in product code LZA (Polymer 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 Kossan International Sdn Bhd3’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Kossan International Sdn Bhd3 by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kossan International Sdn Bhd3’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 “Kossan”

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

Kossan Latex Industries (M)Sdn Bhd 19 Kossan International Sdn Bhd 13

Kossan International Sdn Bhd3

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kossan”