Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)— 510(k) K230395
Substantially EquivalentDurio Ppe Sdn Bhd
FDA 510(k) clearance K230395 for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue), Substantially Equivalent on 2023-07-17. Applicant: Durio Ppe Sdn Bhd. Device class: 2.
Clearance details
- Applicant
- Durio Ppe Sdn Bhd
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Johor Bahru, MY
Recent devices under product code FXX
view all- K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more
- K252534 — Surgical Face Mask (Ear mount)
- K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- K252830 — Disposable Surgical Face Mask (3P00B, C2900)
- K252650 — Disposable Medical Face Mask
Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.