FDA applicant

Supermax Sdn Bhd

Sungai Pelong, Selangor, MY9 decisions1990–20020 recalls

FDA records 9 decisions for Supermax Sdn Bhd (Sungai Pelong, Selangor, MY) from 1990 to 2002: 9 510(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 Supermax Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Supermax Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Supermax 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 “Supermax”

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

Supermax Glove Manufacturing Sdn Bhd 6 Supermax Plastic Products Co., Ltd. 3 Supermax Healthcare Canada-Supermax Medical 2 Supermax Latex Products Sdn. Bhd. 1

Supermax Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Supermax”