510(k) Report

Devices descending from K122717

45 later devices reach Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210256CiRx (R) Surgical MaskNingbo Shun YE Medical Company, Ltd.20210—
+1K173062Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))V&Q Manufacturing Corporation201835—
+1K153409Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)Protect U Guard, LLC20167—
+2K211487MAF GuardMaf Clothing Pvt Ltd Unit-320210—
+2K203388Disposable medical maskEverwin Toys (Dongguan)., Ltd.20210—
+2K203704Surgical face maskJuntech (Jiaxing)Healthcare Materials Co,.Ltd20210—
+2K201095Sovereign America Surgical Face MaskHomtex, Inc.20210—
+2K202628Disposable Medical Face MaskQinghai Zhong Dao Win-Win Medical Protective Equipment Co.,20210—
+2K201974Single-use medical face maskGuangdong Horigen Mother & Baby Products Co., Ltd.20210—
+2K202316Medical mask (Model: KKF-1A)Han Zhaoqing Sporting Goods Company Limited20210—
+2K202904Surgical Face MaskJiangxi Feilikang Medical Technology Co., Ltd.20211—
+2K202843Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.20215—
+2K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd.20212—
+2K202029Medical Surgical MaskBeijing Biosis Healing Biolog Ical Technology Co., Ltd.20202—
+2K201622Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20202—
+2K201479DemeMASKDemetech Corporation202017—
+3K233723Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20240—
+3K231155Biodegradable Medical surgical maskGuangdong Kingfa Sci. & Tech.Co., Ltd.20230—
+3K212649Disposable Surgical Face MaskLyncmed Medical Technology (Beijing) Co., Ltd.20220—
+3K222335Surgical MaskLuoyang Sunmed Devices Co., Ltd.20220—
+3K213450Medical surgical mask (Black mask, Level 1 and Level 3)Guangdong Kingfa Sci. & Tech.Co., Ltd.20220—
+3K212726Disposable Medical Surgical MaskHubei Huaqiang High-Tech Co., Ltd.20220—
+3K213920Kangbeier Surgical Mask (Model: KBR-1001)Xinxiang Kangbeier Medical Technology Co., Ltd.20220—
+3K211750Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)National Bridge Industrial (S.Z.) Co., Ltd.20210—
+3K212302BAYLAB 3-Ply Surgical Mask (BEACON I)Baylab USA, LLC20210—
+3K211295Surgical Mask (sterile)Nanjing 3h Medical Products Co., Ltd.20210—
+3K213406Savvy Mask - Level 3 Surgical Face MaskTexas Medplast, LLC20210—
+3K210813Medical Surgical MaskSichuan Pharmaceutical., Inc.20210—
+3K210908Surgical MaskSichuan Prius Biotechnology Co., Ltd.20210—
+3K210184Wilson Tech Disposable Medical Face MaskWilson Tech (International) Limited20210—
+3K212451Surgical MaskRemade USA, LLC20210—
+3K210391Single-use medical face maskZhuhai Herald Datanetics Limited.20210—
+3K201844Surgical Face Mask, Surgical MaskLear Corporation20210—
+3K203591Single-use Medical Face MaskConod Medical Co., Limited20211—
+3K210518Surgical Face MaskShandong Haidike Medical Products Co., Ltd.20210—
+3K202580Disposable Surgical MaskQingdao Likangyuan Medical Device Co., Ltd.20210—
+3K210030Medical Surgical MaskTianjin Aoshang Outdoor Equipment Co., Ltd.20214—
+3K202607Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs…String King Lacrosse, LLC20210—
+3K210018Disposable Medical MaskDiasia Biomedical Technology Co., Ltd.20210—
+3K202493Medical Face MaskGemtier Medical (Shanghai), Inc.20210—
+4K231719Medical Surgical MaskAzur Medical Company, Inc.20240—
+4K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.20221—
+4K212299Medical Surgical MaskWepon Medical Technology Co., Ltd.20220—
+4K203112Disposable Medical MaskYangzhou Runyi Arts & Crafts Co., Ltd.20210—
+5K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.20260—