Durio Ppe Sdn Bhd

FDA Regulatory Profile

Durio Ppe Sdn Bhd has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest 510(k)
Jul 17, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)Jul 17, 2023