FDA applicant

Betel Care Sdn. Bhd.

Selangor Darul Ehsan, MY4 decisions2000–20220 recalls

FDA records 4 decisions for Betel Care Sdn. Bhd. (Selangor Darul Ehsan, MY) from 2000 to 2022: 4 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and 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 Betel Care Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Betel Care Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?