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Mask, Surgical

FDA product code FXX · 601 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4040
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-11-16 – 2026-03-18
FXX 2025-05-30

Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce

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

K number K243010

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