FDA applicant
Wrp Asia Pacific Sdn. Bhd.
FDA records 46 decisions for Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY) from 1999 to 2024: 46 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 183 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 15 of them its own earlier devices. 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wrp Asia Pacific Sdn. Bhd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
3in 2021
Class I Class II/III not classified
Planning a device like Wrp Asia 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