FDA applicant

Bright Element Sdn Bhd

Subang Jaya, Selangor, MY4 decisions2006–20070 recalls

FDA records 4 decisions for Bright Element Sdn Bhd (Subang Jaya, Selangor, 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 Bright Element Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bright Element 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 “Bright”

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

Bright Spine 3 Bright Uro, Inc. 2 Bright Rubber Industries Private, Ltd. 1 Bright Medical Instruments 1 Bright Horizon Ent. 1

Bright Element Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bright”