510(k) Report

Devices descending from K801036

329 later devices reach Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213617Surgical Face MaskMegasoft (China) Co., Ltd.20221—
+8K212111Myflon Surgical Mask Level 3Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi20220—
+8K213970D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 PlyDanameco Medical Joint Stock Corporation20220—
+8K212046Impertech Surgical Face MaskImpertech Industries, Ltd.20210—
+8K212109Spin Care Disposable Protective Mask Level 3Spintech, LLC20210—
+8K211165Medical Face Masks, Model Name:MY020003Huizhou Jie Bai Purification Co., Ltd.20210—
+8K212526Surgical Face MaskSuzhou Janee Medical Technology Co., Ltd.20210—
+8K210348Disposable Medical Surgical MaskWeihai Dishang Medical Technology Co., Ltd.20210—
+8K211794Disposable surgical maskShanghai No.9 Knitting Mill Co., Ltd.20210—
+8K203112Disposable Medical MaskYangzhou Runyi Arts & Crafts Co., Ltd.20210—
+8K211536Welspun Health Surgical MaskWelspun India Limited20210—
+8K212097Disposable medical surgical maskHebei Titans Hongsen Medical Technology Co., Ltd.20212—
+8K211631Surgical Face MaskMacheng Thimble Technology Investment Co., Ltd.20214—
+8K211353Medical Face MaskShenzhen Lyttop Healthcare Limited20210—
+8K211861TAIJI Professional Series Level 3 Surgical Face MaskTaiji Medical Supplies, Inc.20210—
+8K211363Medical Face MaskHubei Kangning Protective Products Co., Ltd.20210—
+8K211249Altor Safety 3-Ply Surgical Mask (Model:62222)Altor Safety, LLC20210—
+8K210244Disposable Medical Face MaskSuzhou Bolisi Medical Technology Co., Ltd.20210—
+8K211062Medical Face MaskAmmex-Weida (Hubei) Health and Safety Products Co., Ltd.20210—
+9K232797HygenixShenzhen Hygenix Industrial Co., Ltd.20230—
+9K223055Disposable Medical Face MaskXiantao Zhuobo Industrial Co., Ltd.20220—
+9K222697Disposable Medical Face Mask (DF3-001)Wellmed Dental Medical Supply Co., Ltd.20220—
+9K222426Perfetta Moderate Medical Face MaskPhu Bao Group Company Limited20220—
+9K221273Medical Face Mask (M001)Xingyu Medical Tech Co., Ltd.20220—
+9K221272Medical Face MaskShandong Xingyu Gloves Co., Ltd.20222—
+9K221222Surgical Face Mask (HNFM0304)Shanghai Hua EN Industrial Co, Ltd.20221—
+10K230617Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd.20230—
+10K230093Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC20230—
+10K222651Surgical Face MaskXiantao Sanda Industrial Co., Ltd.20220—