ClearanceBrief
Panels › General, Plastic Surgery › Product code FXX · Class 2

Mask, Surgical

Regulation 878.4040

8510(k)s in 12 months (607 all time)
0recalls in 12 months (12 all time)
10recalls that name a 510(k)
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Top companies in FXX

Company510(k)sRecalls
Tecnol New Jersey Wound Care, Inc.110
Owens & Minor (O&M) Halyard, Inc.80
Anago, Inc.70
Protectaide, Inc.70
3M Company60
Guangdong Kingfa Sci. & Tech.Co., Ltd.60
AMD Medicom Inc.05
Tecnol Medical Products, Inc.50
Dukal Corp.40
Kimberly-Clark40
Decided510(k)Device and applicantCode
Mar 18, 2026K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-
O&M Halyard, Inc.
FXX
Mar 3, 2026K252534Surgical Face Mask (Ear mount)
Zhejiang Hangkang Medical Equipment Co., Ltd., CN
FXX
Feb 19, 2026K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
Efofex, Inc.
FXX
Jan 12, 2026K252830Disposable Surgical Face Mask (3P00B, C2900)
Beatles Medical Supplies (Xiantao) Co., Ltd., CN
FXX
Jan 5, 2026K252650Disposable Medical Face Mask
Makrite Industries, Inc., TW
FXX
Dec 22, 2025K243342KP Protective Face Mask
Kp Trading Co., Ltd., KR
FXX
Dec 11, 2025K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
O&M Halyard, Inc.
FXX
Nov 4, 2025K252964PRIMED Surgical and Procedure Masks
Primed Medical Products, Inc., CA
FXX
Sep 17, 2025K251902Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)
Vitacore Industries, Inc., CA
FXX
Jun 18, 2025K250082Procedure mask/Surgical mask/Face mask
Winner Medical Co., Ltd., CN
FXX
May 30, 2025K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO S
Owens & Minor (O&M) Halyard, Inc.
FXX
Nov 12, 2024K242502Aurelia Surgical Mask ASTM Level-3 (2130)
Supermax Healthcare Canada – Supermax Medical, CA
FXX
Oct 18, 2024K240916Surgical Face Mask (Tie on/ Ear loops)
Xiantao Daoqi Plastic Co., Ltd., CN
FXX
Aug 26, 2024K240286PRIMED Surgical Masks and PRIMED Procedure Masks
Primed Medical Products, Inc., CA
FXX
Jul 29, 2024K233723Medical surgical mask
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
FXX
Jul 2, 2024K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Fre
Owens & Minor (O&M) Halyard, Inc.
FXX
Jul 1, 2024K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Proce
Owens & Minor (O&M) Halyard, Inc.
FXX
Jun 21, 2024K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SO
Owens & Minor (O&M) Halyard, Inc.
FXX
Jun 14, 2024K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Flui
Owens & Minor (O&M) Halyard, Inc.
FXX
Jun 7, 2024K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask
Owens & Minor (O&M) Halyard, Inc.
FXX
Jun 6, 2024K232968Grande Medical Masks, Model SF-600
Golden Grande Corp., TW
FXX
Jun 4, 2024K232820HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
Owens & Minor (O&M) Halyard, Inc.
FXX
Apr 18, 2024K240258Disposable Medical Face Mask (M643BE)
Makrite Industries, Inc., TW
FXX
Apr 2, 2024K232112R&G Surgical Mask
R&G Seguridad E Higiene Industrial S.A.C., PE
FXX
Mar 19, 2024K231719Medical Surgical Mask
Azur Medical Company, Inc.
FXX
Jan 8, 2024K232894HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgic
Owens & Minor (O&M) Halyard, Inc.
FXX
Dec 11, 2023K232797Hygenix
Shenzhen Hygenix Industrial Co., Ltd., CN
FXX
Dec 5, 2023K231005Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2
Supermax Healthcare Canada-Supermax Medical, CA
FXX
Nov 7, 2023K231155Biodegradable Medical surgical mask
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
FXX
Oct 2, 2023K232359Surgical face mask
Kingstar Medical (Xianning) Co., Ltd., CN
FXX
Aug 3, 2023K230380Surgical Face Masks, Model: EFMDS-L50Pn BLU
Iris USA
FXX
Jul 28, 2023K2316183 Layer Surgical Mask (134252531)
Original Mattress Factory, Inc.
FXX
Jul 17, 2023K230395Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
Durio Ppe Sdn Bhd, MY
FXX
Jul 3, 2023K230569Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel
Cardinalhealth
FXX
Jun 1, 2023K230617Surgical Face Mask (L 175*95mm)
Henan Chaoya Medical Equipment Co., Ltd., CN
FXX
May 19, 2023K222545Disposable Medical Mask
Guangzhou Fuzelong Hygiene Material Co., Ltd., CN
FXX
Mar 27, 2023K223823Disposable Surgical Face Mask
Efofex, Inc.
FXX
Mar 24, 2023K223236Medline Surgical Face Mask and Medline Procedural Face Mask
Medline Industries, LP
FXX
Mar 13, 2023K221352Surgical Face Mask
Wuhan Huashida Protective Products Co., Ltd., CN
FXX
Mar 8, 2023K221209PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
Padm Medical, Inc., CA
FXX
Mar 6, 2023K230383Savvy Surgical Mask - Level 3
Alg Health, LLC
FXX
Mar 6, 2023K223232Procedure mask/Surgical mask/Face mask
Winner Medical Co., Ltd., CN
FXX
Mar 2, 2023K230093Disposable 4 Layers Surgical Face Mask
Social Medical Supply, LLC
FXX
Feb 7, 2023K223686Medical Protective Masks
Qinhuangdao Taizhi Medical Technology Co., Ltd., CN
FXX
Jan 13, 2023K221682Ideal Med Pro 3-Ply Disposable Face Mask
Jsn Holdings, LLC
FXX
Jan 6, 2023K203380Disposable Surgical Face Mask
Shandong Pop Jeans Intelligent Manufacturing Co., Ltd., CN
FXX
Jan 4, 2023K222483Surgical Face Mask
Hubei Woozon Healthcare Co., Ltd., CN
FXX
Jan 3, 2023K222809Medical Disposable Face Masks
Anqing Mayfield Medical Limited, CN
FXX
Dec 16, 2022K213601Surgical Mask
Wuhan Zonsen Medical Products Co., Ltd., CN
FXX
Dec 15, 2022K220520PM Excellence SEQUR 100 Surgical Face Mask
Pm Excellence, LLC
FXX

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