FXX — Mask, Surgical Class II

FDA Device Classification

Classification Details

Product Code
FXX
Device Class
Class II
Regulation Number
878.4040
Submission Type
Review Panel
HO
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252534zhejiang hangkang medical equipment coSurgical Face Mask (Ear mount)March 3, 2026
K253398efofexDisposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)February 19, 2026
K252830beatles medical supplies (xiantao) coDisposable Surgical Face Mask (3P00B, C2900)January 12, 2026
K252650makrite industriesDisposable Medical Face MaskJanuary 5, 2026
K243342kp trading coKP Protective Face MaskDecember 22, 2025
K252941o and m halyardHALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsDecember 11, 2025
K252964primed medical productsPRIMED Surgical and Procedure MasksNovember 4, 2025
K251902vitacore industriesVitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with SSeptember 17, 2025
K250082winner medical coProcedure mask/Surgical mask/Face maskJune 18, 2025
K243010owens and minor (o and m) halyardFluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804);May 30, 2025
K242502supermax healthcare canada – supermax medicalAurelia Surgical Mask ASTM Level-3 (2130)November 12, 2024
K240916xiantao daoqi plastic coSurgical Face Mask (Tie on/ Ear loops)October 18, 2024
K240286primed medical productsPRIMED Surgical Masks and PRIMED Procedure MasksAugust 26, 2024
K233723guangdong kingfa sci. and tech.coMedical surgical maskJuly 29, 2024
K232824owens and minor (o and m) halyardFLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* EarloopJuly 2, 2024
K232777owens and minor (o and m) halyardFLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, LavendJuly 1, 2024
K232807owens and minor (o and m) halyardFluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869);June 21, 2024
K232812owens and minor (o and m) halyardFluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical June 14, 2024
K232806owens and minor (o and m) halyardHALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops June 7, 2024
K232968golden grandeGrande Medical Masks, Model SF-600June 6, 2024