Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small— 510(k) K233022
Substantially EquivalentOwens & Minor (O&M) Halyard, Inc.
FDA 510(k) clearance K233022 for Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small, Substantially Equivalent on 2024-01-12. Applicant: Owens & Minor (O&M) Halyard, Inc.. Device class: 2.
Clearance details
- Applicant
- Owens & Minor (O&M) Halyard, Inc.
- Product code
- Code MSH
- 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
- Mechanicsville, VA, US
Recent devices under product code MSH
view all- K172963 — Master-Frank N95 Particulate Respirator
- K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
- K160271 — N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
- K141876 — Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
- K121069 — 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
More clearances from Owens & Minor (O&M) Halyard, Inc.
view all- K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804) +5 more
- K232824 — FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) +2 more
- K232777 — FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) +1 more
- K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869) +1 more
- K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113) +3 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.