HIGH FILTRATION ISO-MASK— 510(k) K831148
Substantially EquivalentTecnol New Jersey Wound Care, Inc.
FDA 510(k) clearance K831148 for HIGH FILTRATION ISO-MASK, Substantially Equivalent on 1984-07-17. Applicant: Tecnol New Jersey Wound Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Tecnol New Jersey Wound Care, Inc.
- 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
- Walker, MI, 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 Tecnol New Jersey Wound Care, Inc.
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 →
Recalls naming K831148
K-number listed on FDA's recall record- Z-0728-2025 — O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
- Z-0729-2025 — O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K831148.
Data sourced from openFDA. This site is unofficial and independent of the FDA.