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Mask, Surgical

FDA product code FXX · 601 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4040
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-16 – 2026-03-18

FXX 2022-04-25

Disposable Surgical Face Mask (M01, M02)

Applicant Fomed Industries, Inc.

K number K220512

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FXX 2022-04-07

Dong Hai Xiang Surgical Mask

Applicant Taizhou Donghaixiang Protective Equipment Co., Ltd.

K number K212203

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FXX 2022-04-07

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

Applicant Gri-Alleset, Inc.

K number K210860

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FXX 2022-04-06

Disposable Medical Mask

Applicant Hubei Wanli Protective Products Co., Ltd.

K number K214085

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FXX 2022-04-05

Medical surgical mask (Black mask, Level 1 and Level 3)

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K number K213450

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FXX 2022-03-31

Medical Face Mask

Applicant Hangzhou Runheng Medical Co., Ltd.

K number K213736

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FXX 2022-03-30

INTAI Surgical Mask (non-sterile)

Applicant Intai Technology Corp.

K number K210422

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FXX 2022-03-25

3 Ply Medical Grade Single Use Procedural Disposable Face Mask

Applicant Kdi Med Supply

K number K220637

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FXX 2022-03-25

Medical Surgical Mask (Model: JM92, JM92B)

Applicant Guangdong Jia Mei Biological Technology Co.Ltd

K number K220187

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FXX 2022-03-24

Surgical Face Mask

Applicant Rizhao Sanqi Medical & Health Articles Co., Ltd.

K number K202903

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FXX 2022-03-23

Disposable Medical Surgical Mask

Applicant Hubei Huaqiang High-Tech Co., Ltd.

K number K212726

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FXX 2022-03-14

DWFritz ASM2000

Applicant Dwfritz Automation, Inc.

K number K213894

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FXX 2022-03-14

Yadu Medical Face Mask (Level 1)

Applicant Henan Yadu Industrial Co., Ltd.

K number K212330

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FXX 2022-03-12

Disposable Medical Face Mask

Applicant Xiantao Zhibo Nonwoven Products Co., Ltd.

K number K213806

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FXX 2022-03-08

Medical Face Mask

Applicant Hubei Medlink Healthcare Co., Ltd.

K number K214087

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FXX 2022-03-04

Surgical Mask

Applicant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K number K213358

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FXX 2022-03-02

ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G

Applicant Medtecs (Taiwan) Corp.

K number K203376

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FXX 2022-02-24

ROKI Surgical Mask

Applicant Roki Co., Ltd.

K number K214094

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FXX 2022-02-20

Medical Surgical Mask

Applicant Hunan Zhenheyikang Medical Instrument Co., Ltd.

K number K213724

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FXX 2022-02-19

Surgical Face Mask

Applicant Taiwan Comfort Champ Manufacturing Co., Ltd.

K number K212863

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FXX 2022-02-19

Heartland Health Surgical Mask

Applicant Heartland Health Products

K number K212366

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FXX 2022-02-11

Surgical Face Mask

Applicant Megasoft (China) Co., Ltd.

K number K213617

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FXX 2022-01-28

Surgical Masks

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K number K212120

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FXX 2022-01-26

Surgical Face Mask

Applicant Foshan Nanhai Plus Medical Co, Ltd.

K number K212610

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FXX 2022-01-26

American-Made Surgical Mask

Applicant Armbrust, Inc.

K number K210101

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FXX 2022-01-25

ADI Medical Surgical Face Mask

Applicant Asia Dynamics Inc., D/B/A Adi Medical

K number K213347

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FXX 2022-01-23

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply

Applicant Danameco Medical Joint Stock Corporation

K number K213970

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FXX 2022-01-23

Myflon Surgical Mask Level 3

Applicant Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi

K number K212111

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FXX 2022-01-20

Surgical Face Mask

Applicant Wuhan Raytex Protection Co., Ltd.

K number K203161

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FXX 2022-01-19

Disposable Medical Mask

Applicant Jiangsu Nanfang Medical Co., Ltd.

K number K212826

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FXX 2022-01-18

Medical Face Mask

Applicant Wuxi Yushou Medical Appliances Co., Ltd.

K number K210679

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FXX 2022-01-17

Medical Face Mask

Applicant Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.

K number K212994

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FXX 2022-01-16

Kangbeier Surgical Mask (Model: KBR-1001)

Applicant Xinxiang Kangbeier Medical Technology Co., Ltd.

K number K213920

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FXX 2022-01-16

Disposable Medical Face Mask

Applicant Zhejiang the Purples Protective Products Co.,Ltd

K number K211833

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FXX 2022-01-14

Surgical Mask

Applicant Guangdong Zhizhen Biological Medical Co., Ltd.

K number K212997

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FXX 2022-01-14

Surgical Face Mask

Applicant Jiangxi Ganlong Pharmaceutical Co., Ltd.

K number K212913

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FXX 2022-01-10

Sheng Jing Tang Surgical Mask

Applicant Liaoning Shengjingtang Biotechnology Co., Ltd.

K number K211260

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FXX 2022-01-04

Disposable Medical Surgical Mask

Applicant Jiangxi Bestgrand Health Technology Co., Ltd.

K number K212375

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FXX 2022-01-04

Medical Surgical Mask

Applicant Wepon Medical Technology Co., Ltd.

K number K212299

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FXX 2021-12-24

CPL Surgical Face Mask

Applicant Control Print Limited

K number K213136

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FXX 2021-12-24

Skypro, SP02 Mask (3)

Applicant Skypro Medical Supplies Company

K number K202255

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FXX 2021-12-22

Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield

Applicant Unicoglobal, Inc.

K number K210147

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FXX 2021-12-20

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)

Applicant National Bridge Industrial (S.Z.) Co., Ltd.

K number K211750

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FXX 2021-12-17

Surgical Face Mask

Applicant Zhongshan Saifute Labor Protective Articles Co., Ltd.

K number K212059

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FXX 2021-12-17

Topwide Surgical Face Mask

Applicant Topwide (Hubei) Medical Products Manufacturer

K number K210102

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FXX 2021-12-16

LM Surgical Mask Level 3, LM Surgical Mask Level 2,

Applicant Liberty Mask, LLC

K number K211378

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FXX 2021-12-15

Disposable Surgical Mask

Applicant Heilongjiang Yinjia Medical Equipment Co., Ltd.

K number K212944

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FXX 2021-12-15

Surgical Face Mask (Non-sterile)

Applicant Hubei Kimsoul Industrial Co., Ltd.

K number K212398

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FXX 2021-12-14

Surgical Face Mask

Applicant Xiantao Deming Healthcare Products Co., Ltd.

K number K212574

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FXX 2021-12-14

Surgical Mask

Applicant Chongqing PA Xijia Biotechnology Co., Ltd.

K number K210744

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FXX 2021-12-13

Surgical face mask: F-Y1-A

Applicant Jiande Chaomei Daily Chemicals Co., Ltd.

K number K202794

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FXX 2021-12-11

Medical Surgical Mask

Applicant Nanchang Kanghua Health Materials Co., Ltd.

K number K212867

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FXX 2021-12-08

MAF Guard

Applicant Maf Clothing Pvt Ltd Unit-3

K number K211487

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FXX 2021-12-07

BAYLAB 3-Ply Surgical Mask (BEACON I)

Applicant Baylab USA, LLC

K number K212302

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FXX 2021-12-06

Surgical Face Mask

Applicant Shanghai Yunqing Industrial Co., Ltd.

K number K212235

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FXX 2021-12-06

PMW01 Procedure Mask Level 1

Applicant Defender Safety, Inc.

K number K211772

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FXX 2021-12-03

Surgical Masks

Applicant Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

K number K212807

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FXX 2021-12-02

Puravita Medical Fold Flat Surgical Mask

Applicant Puravita M, LLC

K number K212740

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FXX 2021-12-02

Single-use Surgical Mask

Applicant Taiwan Seafood and Fish Corporation

K number K211773

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FXX 2021-11-30

Disposable Surgical Face Mask

Applicant Anhui Cleanpro Pharmpack Co., Ltd.

K number K211696

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FXX 2021-11-26

Medical surgical mask

Applicant Henan Huibo Medical Co., Ltd.

K number K202842

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FXX 2021-11-24

Surgical Mask (sterile)

Applicant Nanjing 3h Medical Products Co., Ltd.

K number K211295

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FXX 2021-11-23

039 Surgical Face Mask

Applicant Aok Tooling Limited

K number K211956

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FXX 2021-11-18

Savvy Mask - Level 3 Surgical Face Mask

Applicant Texas Medplast, LLC

K number K213406

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FXX 2021-11-18

Impertech Surgical Face Mask

Applicant Impertech Industries , Ltd.

K number K212046

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FXX 2021-11-17

Disposable Surgical Mask

Applicant Suzhou Letian Protective Products Co., Ltd.

K number K210042

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FXX 2021-11-16

Surgical Mask

Applicant Xiantao Dingcheng Non-Woven Product Co., Ltd.

K number K212344

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FXX 2021-11-14

Surgical Face Mask

Applicant Hubei Huanfu Plastic Products Co., Ltd.

K number K212575

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FXX 2021-11-14

Spin Care Disposable Protective Mask Level 3

Applicant Spintech, LLC

K number K212109

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FXX 2021-11-13

Surgical Face mask

Applicant Nantong Taiweishi Medical Technology Co., Ltd.

K number K212264

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FXX 2021-11-09

Surgical Face Mask

Applicant Suzhou Janee Medical Technology Co., Ltd.

K number K212526

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FXX 2021-11-09

Medical Face Masks, Model Name:MY020003

Applicant Huizhou Jie Bai Purification Co., Ltd.

K number K211165

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FXX 2021-11-05

Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))

Applicant Guangzhou Zhengkang Medical Equipment Co.,Ltd

K number K212460

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FXX 2021-11-05

Disposable Medical Face Mask

Applicant Zhejiang Senhong Medical&Instrument Co., Ltd.

K number K202676

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FXX 2021-11-04

Medical Face Mask

Applicant Haian Medigauze Co., Ltd.

K number K212471

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FXX 2021-11-02

Disposable Medical Mask

Applicant Guangdong Lide Medical Technology Co., Ltd.

K number K210222

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FXX 2021-10-25

Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)

Applicant Jiangmen Ningrui Medical Supplies Co., Ltd.

K number K212293

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FXX 2021-10-24

Surgical Face Mask

Applicant Anhui Tiankang Medical Technology Co., Ltd.

K number K212368

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FXX 2021-10-24

Disposable Medical Surgical Mask

Applicant Weihai Dishang Medical Technology Co., Ltd.

K number K210348

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FXX 2021-10-19

Surgical 3D Mask

Applicant Inno Lifecare

K number K203565

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FXX 2021-10-14

Medical Protective Masks

Applicant Qinhuangdao Taizhi Medical Technology Co., Ltd.

K number K212205

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FXX 2021-10-12

Disposable Surgical Mask (Model: YYKZ-01)

Applicant Jiaxing Amazing Travel-Ware Co., Ltd.

K number K210845

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FXX 2021-10-08

Medical Surgical Mask

Applicant Sichuan Pharmaceutical., Inc.

K number K210813

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FXX 2021-10-08

Single-Use Medical Face Mask

Applicant Jiangxi Hongda Medical Equipment Group Co., Ltd.

K number K210622

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FXX 2021-10-04

Surgical Face Mask

Applicant Hubei Yi-Ya Protective Products Co., Ltd.

K number K211899

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FXX 2021-10-04

Private Stock Labs Surgical Face Mask

Applicant J.K. Private Stock, Inc.

K number K211425

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FXX 2021-09-29

UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2

Applicant Universal Incorporation

K number K210513

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FXX 2021-09-28

Disposable surgical mask

Applicant Shanghai No.9 Knitting Mill Co., Ltd.

K number K211794

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FXX 2021-09-28

Surgical Face Mask (Model: CM2006, CM2008, A88)

Applicant Shenzhen Realtone Medical Appliance Co., Ltd.

K number K210878

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FXX 2021-09-26

Surgical Mask

Applicant Sichuan Prius Biotechnology Co., Ltd.

K number K210908

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FXX 2021-09-23

Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

Applicant Zhejiang Lanhine Medical Products, Ltd.

K number K211827

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FXX 2021-09-22

Banyan USA Surgical Mask Level 3

Applicant Banyan USA, LLC

K number K211097

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FXX 2021-09-22

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

Applicant Vr Vertical, LLC Dba Xrgo

K number K210772

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FXX 2021-09-17

WELLTRUST WT-III Mask with Flat Earloop

Applicant Lonestar Meadows, LLC

K number K211751

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FXX 2021-09-17

Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))

Applicant Ningbo Ouhan Medical Device Co., Ltd.

K number K203418

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FXX 2021-09-16

Disposable Medical Mask

Applicant Yangzhou Runyi Arts & Crafts Co., Ltd.

K number K203112

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FXX 2021-09-14

Wilson Tech Disposable Medical Face Mask

Applicant Wilson Tech (International) Limited

K number K210184

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FXX 2021-09-13

Disposable Medical Mask

Applicant Fujian Kang Chen Daily Necessities Co., Ltd.

K number K203455

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FXX 2021-09-11

Surgical face mask

Applicant Sunsmed Protective Products , Ltd.

K number K211296

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FXX 2021-09-10

Surgical Mask

Applicant Remade USA, LLC

K number K212451

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