FDA.report

510(k) K232807

Device
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
Applicant
Owens & Minor (O&M) Halyard, Inc.
510(k) number
K232807
Product code
FXX
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-21
Date received
2023-09-12
Regulation
878.4040
Classification name
Mask, Surgical
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Angela L. Bunn
Address
9120 Lockwood Blvd. Mechanicsville VA US 23116 23116

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code FXX

510(k)DeviceApplicantDecision date
K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.2026-03-18
K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.2026-03-03
K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.2026-02-19
K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.2026-01-12
K252650Disposable Medical Face MaskMakrite Industries, Inc.2026-01-05
K243342KP Protective Face MaskKp Trading Co., Ltd.2025-12-22
K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsO&M Halyard, Inc.2025-12-11
K252964PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc.2025-11-04
K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)Vitacore Industries, Inc.2025-09-17
K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.2025-06-18
K243010Fluidshield * 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 ProceOwens & Minor (O&M) Halyard, Inc.2025-05-30
K242502Aurelia Surgical Mask ASTM Level-3 (2130)Supermax Healthcare Canada – Supermax Medical2024-11-12
K240916Surgical Face Mask (Tie on/ Ear loops)Xiantao Daoqi Plastic Co., Ltd.2024-10-18
K240286PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc.2024-08-26
K233723Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.2024-07-29