FDA.reportPublic FDA data

510(k) K222266

Device
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
Applicant
Jingzhou Haixin Green Cross Medical Products Co., Ltd.
510(k) number
K222266
Product code
FXX
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-26
Date received
2022-07-28
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
No

Applicant Contact#

Contact
Lei Da
Address
Yongxing N. Rd. #2 Jingzhou Hubei Jingzhou CN 434007 434007

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FXX#

510(k), Device, Applicant table
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