FDA applicant
Seltom Pacific Sdn. Bhd.
FDA records 7 decisions for Seltom Pacific Sdn. Bhd. (Petaling Jaya, Selangor, MY) from 1999 to 2001: 7 510(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 Seltom Pacific Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Seltom Pacific Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Seltom Pacific Sdn. 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) Report