FDA applicant

Promedica Sdn. Bhd.

Selangor, Malaysia, MY1 decision1989–19890 recalls

FDA records 1 decision for Promedica Sdn. Bhd. (Selangor, 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 Promedica Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Promedica Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Promedica 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 “Promedica”

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

Promedica Products, Inc. 6 Promedica, Inc. 2

Promedica Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Promedica”