FDA applicant

3A Glove Sdn. Bhd.

Senai, MY2 decisions2023–20230 recalls

FDA records 2 decisions for 3A Glove Sdn. Bhd. (Senai, MY) in 2023: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 3A Glove Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — 3A Glove Sdn. Bhd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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3A Glove Sdn. Bhd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?