FDA applicant

Supermax Latex Products Sdn. Bhd.

Sungai Buloh, Selangor, MY1 decision1998–19980 recalls

FDA records 1 decision for Supermax Latex Products Sdn. Bhd. (Sungai Buloh, Selangor, MY) in 1998: 1 510(k) clearance. All are in product code 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 Supermax Latex Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Supermax Latex Products Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Supermax”

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

Supermax Sdn Bhd 9 Supermax Glove Manufacturing Sdn Bhd 6 Supermax Plastic Products Co., Ltd. 3 Supermax Healthcare Canada-Supermax Medical 2

Supermax Latex Products Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Supermax”