FDA applicant

Supermax Plastic Products Co., Ltd.

Chino, CA3 decisions2010–20150 recalls

FDA records 3 decisions for Supermax Plastic Products Co., Ltd. (Chino, CA) from 2010 to 2015: 3 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Supermax Plastic Products Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Supermax Plastic Products Co., Ltd.’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 Healthcare Canada-Supermax Medical 2 Supermax Latex Products Sdn. Bhd. 1

Supermax Plastic Products Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Supermax”