FDA applicant

High Momentum Sdn Bhd

Selangor Daurl Ehsan, MY4 decisions2006–20070 recalls

FDA records 4 decisions for High Momentum Sdn Bhd (Selangor Daurl Ehsan, MY) from 2006 to 2007: 4 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and 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 High Momentum Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “High”

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

High Technology Products S.L.U 3 High Country Ent. 1

High Momentum Sdn Bhd

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “High”