FDA applicant
Pwa Industries Sdn. Bhd.
FDA records 11 decisions for Pwa Industries Sdn. Bhd. (Kuantan, Pahang, MY) from 1995 to 2001: 11 510(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 Pwa Industries Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pwa Industries Sdn. Bhd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pwa Industries 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