510(k) Report

Devices descending from K160269

60 later devices reach Surgical Face Masks (Ear loops and Tie-on) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232968Grande Medical Masks, Model SF-600Golden Grande Corp.20240—
+1K203528KNH Surgical Face MaskKnh Surgical Face Mask20220—
+1K221534Surgical Face Masks (Ear Loops And Tie-On)San-M Package Co., Ltd.20220—
+1K220944PointCore Surgical MaskPointcore, Inc.20220—
+1K221409Paneffort 3-ply Surgical and Procedural MasksPaneffort, LLC20220—
+1K202903Surgical Face MaskRizhao Sanqi Medical & Health Articles Co., Ltd.20222—
+1K212120Surgical MasksHubei Xinxin Non-Woven Co., Ltd.20221—
+1K212610Surgical Face MaskFoshan Nanhai Plus Medical Co, Ltd.20220—
+1K212994Medical Face MaskGuangzhou Quantum Laser Intelligent Equipment Co., Ltd.20220—
+1K212471Medical Face MaskHaian Medigauze Co., Ltd.20211—
+1K210222Disposable Medical MaskGuangdong Lide Medical Technology Co., Ltd.20210—
+1K210622Single-Use Medical Face MaskJiangxi Hongda Medical Equipment Group Co., Ltd.20211—
+1K211066Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask…Homtex, Inc.20210—
+1K211462Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face MaskXiantao S&J Protective Products Co., Ltd.20213—
+1K211454Surgical maskJiangsu Xingtong Biotechnology Group Co., Ltd.20212—
+1K210380Medical surgical maskShantou T&K Medical Equipment Factory Co.,Ltd20210—
+1K210524Surgical MaskChangzhou Holymed Products Co., Ltd.20210—
+1K210767Surgical Masks, Model:FE-1Hunan Triplex Precision Medical Devices Co., Ltd.20210—
+1K202128Allmed Surgical Face Masks (Ear loops)Allmed Medical Products Co., Ltd.20210—
+1K202697United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid…United Sewing Automation, Inc.20210—
+1K2025983 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3…3A Medical Products Co., Ltd.20211—
+1K202387Disposable Surgical Face MaskGuangdong Bida Medical Technology Co., Ltd.20210—
+1K202759Disposable medical surgical maskChongqing Coe Display Technology Co., Ltd.20210—
+1K201718GD Disposable Medical Face MaskJiangsu Guangda Medical Material Group Co., Ltd.20210—
+1K201127DEFEND Ear-loop Face MasksYoung Dental Manufacturing Co. 1, LLC20210—
+1K202424Surgical Mask-Models CR02-2, CR02Foshan Xinbao Technology Co., Ltd.20213—
+1K202905Disposable Face MaskJiangsu Excellence Medical Supplies Co., Ltd.20211—
+1K203776Surgical Masks, Model SNN200640 & MN112Sq Medical Supplies, Inc.20210—
+1K203064ICU Health Surgical MaskPlastikon Industries20210—
+1K201624Spin Care Disposable Protective MaskSpintech, LLC20210—
+1K210225Surgical Face MaskFeng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.20210—
+1K202240Disposable Surgical Mask/Fluid Resistant Procedure MaskLhm Medical Technology (Hong Kong) Limited20210—
+1K201868Phyziofit Medical Surgical MaskWellpower Sporting Goods Co., Ltd.20210—
+1K202341Disposable Surgical MaskShanghai Jianzhong Medical Packaging Co., Ltd.20210—
+1K201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2…Dukal Corporation20210—
+1K202491Disposable Surgical Face MaskJiangsu Newvalue Medical Products Co., Ltd.20214—
+1K201754JianYu Surgical MaskJiangsu Jianyu Health Medical Co., Ltd.20200—
+1K202061Medical Face maskJiangsu Province Jianerkang Medical Dressing Co., Ltd.20202—
+1K201991Medical surgical maskShenzhen Everwin Precision Technology Co., Ltd.20200—
+2K252650Disposable Medical Face MaskMakrite Industries, Inc.20260—
+2K222545Disposable Medical MaskGuangzhou Fuzelong Hygiene Material Co., Ltd.20230—
+2K223236Medline Surgical Face Mask and Medline Procedural Face MaskMedline Industries, LP20230—
+2K221352Surgical Face MaskWuhan Huashida Protective Products Co., Ltd.20230—
+2K223068Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)Guangdong Golden Leaves Technology Development Co., Ltd.20220—
+2K220067Medical Surgery Mask, Model:2626-7Dongguan Missadola Technology Co., Ltd.20220—
+2K221838Surgical Face Mask (HNFM0103)Shanghai Hua EN Industrial Co, Ltd.20220—
+2K220191Disposable Face MaskJiujiang Taixin Technology Co., Ltd.20220—
+2K220194Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20222—
+2K212330Yadu Medical Face Mask (Level 1)Henan Yadu Industrial Co., Ltd.20220—
+2K213724Medical Surgical MaskHunan Zhenheyikang Medical Instrument Co., Ltd.20220—
+2K203161Surgical Face MaskWuhan Raytex Protection Co., Ltd.20220—
+2K211833Disposable Medical Face MaskZhejiang the Purples Protective Products Co.,Ltd20220—
+2K212997Surgical MaskGuangdong Zhizhen Biological Medical Co., Ltd.20220—
+2K212293Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)Jiangmen Ningrui Medical Supplies Co., Ltd.20213—
+2K210845Disposable Surgical Mask (Model: YYKZ-01)Jiaxing Amazing Travel-Ware Co., Ltd.20210—
+3K250082Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20250—
+3K223232Procedure mask/Surgical mask/Face maskWinner Medical Co., Ltd.20231—
+3K222204Medical Surgical MaskGuangzhou Zhengkang Medical Equipment Co.,Ltd20220—
+3K221173Surgical Mask (Model: 0868F, 0866F)Jiangxi Sanhao Medical Instruments Co.,Ltd20220—
+3K220187Medical Surgical Mask (Model: JM92, JM92B)Guangdong Jia Mei Biological Technology Co.Ltd20220—