FDA applicant

Sime Darby USA

Chatham, NJ2 decisions1989–19900 recalls

FDA records 2 decisions for Sime Darby USA (Chatham, NJ) from 1989 to 1990: 2 510(k) clearances. 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 Sime Darby USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sime Darby USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sime”

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

Sime Health, Ltd. 11

Sime Darby USA

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sime”