FDA applicant

Maika Rubber Products Sdn Bhd

Libertyville, IL1 decision1998–19980 recalls

FDA records 1 decision for Maika Rubber Products Sdn Bhd (Libertyville, IL) in 1998: 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 Rubber Products Sdn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Maika Rubber Products Sdn Bhd since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Maika Rubber Products 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 “Maika”

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

Maika Holdings Sdn. Bhd. 1

Maika Rubber Products Sdn Bhd

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Maika”