Fluidshield* 2 Fog-Free Surgical Mask (62113) +3 more— 510(k) K232812

Clearance details

Device name as filed

Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)

Applicant

Owens & Minor (O&M) Halyard, Inc.

Product code

Code FXX

Device class

Class 2

Regulation

21 CFR 878.4040

Advisory panel

General, Plastic Surgery

Date received

2023-09-12

Decision date

2024-06-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mechanicsville, VA, US

• K251967 — HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops +1 more2026-03-18
• K252534 — Surgical Face Mask (Ear mount)2026-03-03
• K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)2026-02-19
• K252830 — Disposable Surgical Face Mask (3P00B, C2900)2026-01-12
• K252650 — Disposable Medical Face Mask2026-01-05

• K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804) +5 more2025-05-30
• K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) +2 more2024-07-02
• K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) +1 more2024-07-01
• K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869) +1 more2024-06-21
• K232806 — HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) +1 more2024-06-07

Injury

137

Total

137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →