FDA applicant

Emerald Glove Manufacturing Sdn Bhd

Taiping, MY1 decision2022–20220 recalls

FDA records 1 decision for Emerald Glove Manufacturing Sdn Bhd (Taiping, MY) in 2022: 1 510(k) clearance. All are in product code 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 Emerald Glove Manufacturing Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Emerald Glove Manufacturing Sdn Bhd by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Emerald Glove Manufacturing 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 “Emerald”

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

Emerald Medical, Inc. 4

Emerald Glove Manufacturing Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Emerald”