FDA applicant

Mega Wijaya Sdn. Bhd.

Malaysia, MY1 decision1989–19890 recalls

FDA records 1 decision for Mega Wijaya Sdn. Bhd. (Malaysia, MY) in 1989: 1 510(k) clearance. 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 Mega Wijaya Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mega Wijaya Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mega Wijaya 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 “Mega”

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

Mega Medical, Inc. 7 Mega Motion, Inc. 4 Mega Electronics, Ltd. 4 Mega Services 1 Mega-Tech Intl., Inc. 1 Mega Meditex, Ltd. 1

Mega Wijaya Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Mega”