510(k) Report

FDA applicant

Medi Legion Sdn.Bhd

Kuala Langat, MY1 decision2021–20210 recalls

FDA records 1 decision for Medi Legion Sdn.Bhd (Kuala Langat, MY) in 2021: 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 Medi Legion Sdn.Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Medi Legion Sdn.Bhd by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Medi”

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