FDA applicant

Wembley Rubber Products (M) Sdn Bhd

Salak Tinggi, Sepang Selangor, MY61 decisions1990–19993 recalls

FDA records 61 decisions for Wembley Rubber Products (M) Sdn Bhd (Salak Tinggi, Sepang Selangor, MY) from 1990 to 1999: 61 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and KGO (Surgeon'S Gloves). 3 recalls are 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 Wembley Rubber Products (M) Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wembley Rubber Products (M) Sdn Bhd since 2007.

Recalls per year

3in 2021

2007high 3 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Wembley Rubber Products (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 “Wembley”

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

Wembley Rubber Products 1

Wembley Rubber Products (M) Sdn Bhd

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Wembley”