FDA applicant
Hwa Teh Industrial Sdn. Bhd.
FDA records 6 decisions for Hwa Teh Industrial Sdn. Bhd. (Batang Berjuntai, MY) from 1989 to 2001: 6 510(k) clearances. 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
How often FDA has decided Hwa Teh Industrial Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hwa Teh Industrial Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hwa Teh Industrial 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