FDA applicant

Maika Holdings Sdn. Bhd.

Tun Ismail, 50350 Kuala, MY1 decision1989–19890 recalls

FDA records 1 decision for Maika Holdings Sdn. Bhd. (Tun Ismail, 50350 Kuala, 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 Maika Holdings Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Maika Holdings Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Maika Holdings 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 “Maika”

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

Maika Rubber Products Sdn Bhd 1

Maika Holdings Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Maika”