DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR— 510(k) K021546
Substantially EquivalentCreative Contract (M) Sdn Bhd
FDA 510(k) clearance K021546 for DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR, Substantially Equivalent on 2003-03-05. Applicant: Creative Contract (M) Sdn Bhd. Device class: 2.
Clearance details
- Applicant
- Creative Contract (M) 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
- Sand Springs, OK, US
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
More clearances from Creative Contract (M) Sdn Bhd
view allAdverse 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.