510(k) Report

FDA applicant

Seal Polymer Industries Bhd.

Lahat, Ipoh, Perak, MY13 decisions1992–20040 recalls

FDA records 13 decisions for Seal Polymer Industries Bhd. (Lahat, Ipoh, Perak, MY) from 1992 to 2004: 13 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and LZA (Polymer 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 Seal Polymer Industries Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seal Polymer Industries Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Seal Polymer Industries 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 “Seal”

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