FDA applicant

Dynacare Sdn Bhd

Sitiawan, MY1 decision2023–20230 recalls

FDA records 1 decision for Dynacare Sdn Bhd (Sitiawan, 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 Dynacare Sdn Bhd’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 — Dynacare Sdn Bhd by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Dynacare Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?