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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K232812
Device Name 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.
9120 Lockwood Blvd.
Mechanicsville,  VA  23116
Applicant Contact Angela L. Bunn
Correspondent
Owens & Minor (O&M) Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Correspondent Contact Angela L. Bunn
Regulation Number878.4040
Classification Product Code
FXX  
Date Received09/12/2023
Decision Date 06/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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