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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 2021-03-25

Surgical Masks, Model SNN200640 & MN112

Applicant Sq Medical Supplies, Inc.

K number K203776

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FXX 2021-03-25

BRS Procedure Face Mask

Applicant Blackbriar Regulatory Services, LLC

K number K202824

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FXX 2021-03-25

Disposable Medical Mask

Applicant Hangzhou Qianzhiya Sanitary Products Co., Ltd.

K number K202133

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FXX 2021-03-24

Medical disposable face mask non sterile

Applicant Guangdong Zhong Ling Industrial Group Co., Ltd.

K number K202650

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FXX 2021-03-23

ICU Health Surgical Mask

Applicant Plastikon Industries

K number K203064

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FXX 2021-03-19

Disposable Medical Face Mask

Applicant Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,

K number K202628

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FXX 2021-03-19

Sovereign America Surgical Face Mask

Applicant Homtex, Inc.

K number K201095

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FXX 2021-03-18

Spin Care Disposable Protective Mask

Applicant Spintech, LLC

K number K201624

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FXX 2021-03-16

MIPLNI YK-244 Disposable Surgical Mask

Applicant Hunan Yuankang Biological Technology Co., Ltd.

K number K210487

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FXX 2021-03-15

Single-Use Surgical Mask

Applicant Qiqihar Hengxin Medical Supplies, Ltd.

K number K201924

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FXX 2021-03-15

Medical Surgical Mask

Applicant Hangzhou Mycode Bio-Medicine Co., Ltd.

K number K201698

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FXX 2021-03-12

AIC disposable medical mask

Applicant The Aleen International Corporation

K number K203775

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FXX 2021-03-10

Surgical Face Mask

Applicant Wanxinda (Guangzhou) Technology Product Co., Ltd.

K number K202548

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FXX 2021-03-10

Surgical Mask

Applicant Allmed Medical Products Co., Ltd.

K number K202411

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FXX 2021-03-10

Surgical Face Mask

Applicant Hunan Eexi Technology & Service Co., Ltd.

K number K202161

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FXX 2021-03-09

Nordiwell Surgical Face Mask

Applicant Changzhou Combat Protective Equipment Co., Ltd.

K number K210181

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FXX 2021-03-09

Disposable Medical Face Mask

Applicant Wanxinda (Guangzhou) Technology Product Co., Ltd.

K number K202710

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FXX 2021-03-09

Surgical Mask

Applicant Allmed Medical Products Co., Ltd.

K number K202409

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FXX 2021-03-09

Surgical Face Mask

Applicant Jiangsu Micsafe Medical Technology Co., Ltd.

K number K202205

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FXX 2021-03-08

Disposable Medical Face Mask

Applicant Hunan Eexi Technology & Service Co., Ltd.

K number K202439

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FXX 2021-03-07

Single-use medical face mask

Applicant Guangdong Horigen Mother & Baby Products Co., Ltd.

K number K201974

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FXX 2021-03-05

Surgical Mask

Applicant Bdc Dental Corporation , Ltd.

K number K203425

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FXX 2021-03-04

Surgical Face Mask

Applicant Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.

K number K210225

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FXX 2021-03-04

Disposable medical mask

Applicant U-Play Products Corporation

K number K202137

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FXX 2021-03-03

Medical mask (Model: KKF-1A)

Applicant Han Zhaoqing Sporting Goods Company Limited

K number K202316

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FXX 2021-03-02

IFM Surgical Mask Model SM3

Applicant Fssc, LLC

K number K202214

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FXX 2021-03-02

Surgical Mask-Model Number: Ear Loop, Flat-Pleated

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K201852

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FXX 2021-02-25

Surgical Masks

Applicant Bain Medical Equipment (Guangzhou) Co., Ltd.

K number K203524

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FXX 2021-02-25

Disposable Surgical Mask/Fluid Resistant Procedure Mask

Applicant Lhm Medical Technology (Hong Kong) Limited

K number K202240

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FXX 2021-02-22

Phyziofit Medical Surgical Mask

Applicant Wellpower Sporting Goods Co., Ltd.

K number K201868

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FXX 2021-02-19

iMask Disposable Surgical Face Mask

Applicant Pac-Dent, Inc.

K number K201182

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FXX 2021-02-18

Surgical Face Mask (non-sterile)

Applicant Nantong Taiweishi Medical Technology Co., Ltd.

K number K203426

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FXX 2021-02-16

Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On

Applicant Dukal Corporation

K number K201732

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FXX 2021-02-12

Disposable Surgical Mask

Applicant Shanghai Jianzhong Medical Packaging Co., Ltd.

K number K202341

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FXX 2021-02-12

Surgical Face Mask

Applicant Amphastar Nanjing Pharmaceuticals, Inc.

K number K201545

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FXX 2021-02-10

Standard Procedure Mask, Standard Surgical Mask

Applicant Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.

K number K202605

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FXX 2021-02-09

nPro Surgical Mask

Applicant Np Medical, Inc.

K number K203265

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FXX 2021-02-05

Freudenberg Surgical Mask

Applicant Freudenberg Performance Materials LP

K number K210063

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FXX 2021-02-05

Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

Applicant Dukal Corporation

K number K201421

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FXX 2021-02-04

Medical Face Mask

Applicant Gemtier Medical (Shanghai), Inc.

K number K202493

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FXX 2021-02-03

Medical Face Masks

Applicant Guilin Hbm Sanitary Protections, Inc.

K number K202627

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FXX 2021-02-02

Disposable Medical Surgical Mask

Applicant Improve Medical (Hunan) Co., Ltd.

K number K202511

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FXX 2021-02-02

Medical Face Mask

Applicant Gemtier Medical (Shanghai), Inc.

K number K202331

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FXX 2021-02-02

Disposable Medical Surgical Masks

Applicant Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.

K number K202323

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FXX 2021-02-02

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

Applicant Ecoguard, Inc.

K number K202096

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FXX 2021-01-29

Protective Face Mask for Medical Use

Applicant Hunan Heng Chang Pharmaceutical Co., Ltd.

K number K202358

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FXX 2021-01-22

Surgical Mask

Applicant Jiangsu Medpure Biological Technology Co., Ltd.

K number K202640

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FXX 2021-01-21

Surgical Face Mask

Applicant Jiangxi Feilikang Medical Technology Co., Ltd.

K number K202904

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FXX 2021-01-21

Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask

Applicant Premier Guard USA, LLC

K number K202595

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FXX 2021-01-15

Medical Protective Mask

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

K number K202107

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FXX 2021-01-13

Procedure face mask (Model: KKF-2A)

Applicant Han Zhaoqing Sporting Goods Company Limited

K number K202314

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FXX 2021-01-12

Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)

Applicant B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.

K number K202843

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FXX 2021-01-12

Disposable Medical Surgical Mask

Applicant Tianjin Saiyuan Technology Co., Ltd.

K number K201625

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FXX 2021-01-11

Medical Surgical Mask-Model MP002-5, MP002-6

Applicant Jiangmen Sure&Me Medical Product Co., Ltd.

K number K202577

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FXX 2021-01-06

Medical Surgical Masks-Non Sterile

Applicant Shandong T&F Nonwoven Co., Ltd.

K number K202594

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FXX 2021-01-06

Disposable Surgical Face Mask

Applicant Jiangsu Newvalue Medical Products Co., Ltd.

K number K202491

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FXX 2021-01-04

Disposable Medical Face Masks

Applicant Jiangxi Sanxin Medtec Co., Ltd.

K number K202719

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FXX 2020-12-31

Nordiwell Medical Face Mask

Applicant Changzhou Combat Protective Equipment Co., Ltd.

K number K202615

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FXX 2020-12-30

JianYu Surgical Mask

Applicant Jiangsu Jianyu Health Medical Co., Ltd.

K number K201754

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FXX 2020-12-23

Medical Face mask

Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

K number K202061

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FXX 2020-12-22

Disposable Medical Surgical Face Masks

Applicant Guangdong Kaidi Garments Co.,Ltd

K number K202211

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FXX 2020-12-16

Medical Surgical Mask

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K number K202029

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FXX 2020-12-14

Medical Face Mask

Applicant Shandong Shengquan New Material Co., Ltd.

K number K201629

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FXX 2020-12-09

Disposable Surgical Mask

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K number K201893

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FXX 2020-12-03

Medical Mask

Applicant Zhende Medical Co., Ltd.

K number K201729

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FXX 2020-12-01

BASE4 Disposable Medical Mask

Applicant Base4 Group, Inc.

K number K202069

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FXX 2020-11-24

Medical surgical mask

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

K number K201622

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FXX 2020-11-23

Medical surgical mask

Applicant Shenzhen Everwin Precision Technology Co., Ltd.

K number K201991

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FXX 2020-11-20

Medical surgical mask

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

K number K202139

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FXX 2020-10-07

Livocare Surgical Mask

Applicant Andon Health Co, Ltd.

K number K201380

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FXX 2020-09-25

Surgical Face Mask

Applicant Jiangxi 3l Medical Products Group Co., Ltd.

K number K202277

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FXX 2020-09-18

Disposable Surgical Mask

Applicant Unisources Group, LLC

K number K202463

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FXX 2020-09-17

Single-Use Surgical Mask With Ear Loop

Applicant Qiqihar Hengxin Medical Supplies, Ltd.

K number K201691

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FXX 2020-09-08

Surgical Mask-Model Number CW01

Applicant Hunan Heng Chang Pharmaceutical Co., Ltd.

K number K202354

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FXX 2020-09-08

Disposable Medical Face Mask

Applicant Jkh USA, LLC

K number K201470

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FXX 2020-09-04

Protective Face Mask for Medical Use

Applicant Shandong Shengquan New Material Co., Ltd.

K number K201537

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FXX 2020-09-04

Plain Surgical Mask

Applicant Aok Tooling Limited

K number K201517

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FXX 2020-08-26

Motex Anti-Fog Surgical Face Mask

Applicant Modern Healthcare Corp.

K number K201549

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FXX 2020-08-26

Single-use Surgical Mask

Applicant Byd Precision Manufacturer Co., Ltd.

K number K200923

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FXX 2020-08-19

Asept Surgical Face Mask

Applicant Pfm Medical, Inc.

K number K201137

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FXX 2020-08-12

Surgical Mask

Applicant C & S Paper Yunfu Co., Ltd.

K number K201871

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FXX 2020-07-24

DemeMASK

Applicant Demetech Corporation

K number K201479

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FXX 2020-04-23

Surgical Face Mask

Applicant Mexpo International, Inc.

K number K200847

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FXX 2020-04-06

ClearMask Transparent Surgical Face Mask

Applicant Clearmask, LLC

K number K200576

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FXX 2019-12-02

Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip

Applicant Cardinal Health200, LLC

K number K192374

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FXX 2019-09-11

3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask

Applicant 3M Healthcare

K number K191355

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FXX 2019-05-27

Surgical Face Mask

Applicant Wuhan Dymex Healthcare Co., Ltd.

K number K182515

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FXX 2019-01-24

Surgical Face Mask

Applicant Xiantao Zhibo Non-Woven Products Co., Ltd.

K number K182514

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FXX 2018-07-31

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield

Applicant 3M Healthcare

K number K180874

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FXX 2018-03-01

Technoweb Surgical Mask

Applicant Yts Global, Inc.

K number K172500

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FXX 2018-01-25

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))

Applicant V&Q Manufacturing Corporation

K number K173062

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FXX 2017-08-15

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

Applicant Prestige Ameritech

K number K171162

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FXX 2016-11-15

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

Applicant Protect U Guard, LLC

K number K153409

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FXX 2016-09-06

Surgical Face Masks (Ear loops and Tie-on)

Applicant San-M Package Co., Ltd.

K number K160269

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FXX 2016-08-26

Skypro, SP01 Mask

Applicant Skypro Medical Supplies Company

K number K152197

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FXX 2016-06-15

Disposable Surgical Face Mask

Applicant Xiantao Rayxin Medical Products Co., Ltd.

K number K153496

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FXX 2016-06-03

Communicator Surgical Facemask with Clear Window

Applicant Prestige Ameritech , Ltd.

K number K152561

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FXX 2013-12-20

KC 300 SURGICAL MASK

Applicant Kimberly-Clark Corp.

K number K131879

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FXX 2013-07-17

GREENCROSS SURGICAL MASK

Applicant Jingzhou Haixin Green Cross Medical Products Co.,L

K number K123787

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FXX 2013-05-20

ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P

Applicant Acme Filter Mask, Inc.

K number K123115

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