FDA applicant
Seal Polymer Industries Bhd.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Seal”
FDA records each applicant name separately; these may or may not be the same firm.