FDA applicant

Ivory Gloves Sdn. Bhd.

Kamunting, MY1 decision2022–20220 recalls

FDA records 1 decision for Ivory Gloves Sdn. Bhd. (Kamunting, 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 Ivory Gloves 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 — Ivory Gloves Sdn. Bhd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ivory Gloves 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 “Ivory”

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

Ivory Super Holdco Inc. / Zest Anchors, LLC 1 Ivory Super Holdco, Incp. 1 Ivory Instruments Co. 1

Ivory Gloves Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ivory”