FDA applicant

Biopro (M) Sdn Bhd

Port Klang, MY5 decisions1998–20000 recalls

FDA records 5 decisions for Biopro (M) Sdn Bhd (Port Klang, MY) from 1998 to 2000: 5 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex 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 Biopro (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biopro (M) Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biopro (M) Sdn Bhd’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Biopro”

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

Biopro, Inc. 41

Biopro (M) Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biopro”