510(k) Report

FDA applicant

Marcon Rubber Industry Sdn. Bhd.

Philadelphia, PA1 decision1989–19890 recalls

FDA records 1 decision for Marcon Rubber Industry Sdn. Bhd. (Philadelphia, PA) 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 Marcon Rubber Industry Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Marcon Rubber Industry Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Marcon Rubber Industry 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 “Marcon”

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