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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 2021-09-08

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask

Applicant Zhejiang Lanhine Medical Products, Ltd.

K number K211832

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FXX 2021-09-03

Altor Safety 4-Ply Surgical Mask (Model:62232)

Applicant Altor Safety, LLC

K number K211762

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FXX 2021-09-01

Welspun Health Surgical Mask

Applicant Welspun India Limited

K number K211536

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FXX 2021-08-28

Surgical Mask

Applicant Tianchang Kanghui Protective Products Co, Ltd.

K number K211255

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FXX 2021-08-27

Surgical mask

Applicant Ningbo Jingeao Electronics, Inc.

K number K202746

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FXX 2021-08-25

Disposable Surgical Mask (non sterile)

Applicant Qinhuangdao Taizhi Medical Technology Co., Ltd.

K number K211451

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FXX 2021-08-23

Disposable medical face mask

Applicant Ningbo Jingeao Electronics, Inc.

K number K202745

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FXX 2021-08-19

WYZ Surgical Mask

Applicant Wyz Medical Supplies, LLC

K number K211576

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FXX 2021-08-19

Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask

Applicant Xiantao S&J Protective Products Co., Ltd.

K number K211462

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FXX 2021-08-19

Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3

Applicant Homtex, Inc.

K number K211066

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FXX 2021-08-19

ECOMA Level 2 Disposable Surgical Mask with Ear Loops

Applicant Xianning Eco Medical Articles Co., Ltd.

K number K210698

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FXX 2021-08-19

CiRx (R) Surgical Mask

Applicant Ningbo Shun YE Medical Company, Ltd.

K number K210256

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FXX 2021-08-18

Disposable medical surgical mask

Applicant Hebei Titans Hongsen Medical Technology Co., Ltd.

K number K212097

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FXX 2021-08-18

Surgical Face Mask

Applicant Macheng Thimble Technology Investment Co., Ltd.

K number K211631

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FXX 2021-08-18

Surgical mask

Applicant Jiangsu Xingtong Biotechnology Group Co., Ltd.

K number K211454

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FXX 2021-08-11

Surgical mask

Applicant Shandong Shengquan New Materials Co., Ltd.

K number K211552

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FXX 2021-08-11

Medical Face Mask

Applicant Shenzhen Lyttop Healthcare Limited

K number K211353

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FXX 2021-08-11

Disposable Face Mask

Applicant Chaozhou Cecilia Technology Co., Ltd.

K number K203152

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FXX 2021-08-04

Disposable Surgical Face Mask

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K number K210643

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FXX 2021-08-03

Surgical Face Mask

Applicant Zhejiang Hongyu Medicali Commodity Co., Ltd.

K number K211897

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FXX 2021-08-02

Disposable Medical Mask

Applicant Dong Guan Kinyet Metal Products Co., Ltd.

K number K203174

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FXX 2021-07-30

MEO Med Disposable Medical Face Mask

Applicant Fujian Meo Medical Technology Limited

K number K210870

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FXX 2021-07-28

TAIJI Professional Series Level 3 Surgical Face Mask

Applicant Taiji Medical Supplies, Inc.

K number K211861

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FXX 2021-07-28

Surgical Mask

Applicant Honeywell Safety Products

K number K211497

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FXX 2021-07-28

Purism Disposable Surgical Mask

Applicant Chuzhou Daddy'S Choice Science and Technology Co., Ltd.

K number K210856

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FXX 2021-07-28

Disposable Surgical Face Mask

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K number K210409

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FXX 2021-07-25

MASC Surgical Mask

Applicant Mid-America Safety Corp.

K number K211984

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FXX 2021-07-24

Medical Face Mask

Applicant Hubei Kangning Protective Products Co., Ltd.

K number K211363

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FXX 2021-07-23

Altor Safety 3-Ply Surgical Mask (Model:62222)

Applicant Altor Safety, LLC

K number K211249

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FXX 2021-07-22

Single-use medical face mask

Applicant Zhuhai Herald Datanetics Limited.

K number K210391

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FXX 2021-07-21

Single-Use Surgical Mask Model FE2311B

Applicant Byd Precison Manufacturer Co., Ltd.

K number K210970

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FXX 2021-07-21

Surgical face mask (Model: Flat Ear Loop/CN102)

Applicant Crown Name Disposable Hygiene Products Fty., Ltd.

K number K203534

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FXX 2021-07-16

Velguard Surgical Face Mask

Applicant Esstee Exports Health Care Division

K number K210761

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FXX 2021-07-15

Disposable Procedural Ear-loop Face Mask

Applicant Changzhou Dsb Medical Co., Ltd.

K number K211042

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FXX 2021-07-14

Surgical Face Mask, Surgical Mask

Applicant Lear Corporation

K number K201844

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FXX 2021-07-12

Disposable Medical Face Mask

Applicant Suzhou Bolisi Medical Technology Co., Ltd.

K number K210244

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FXX 2021-07-08

Medical surgical mask

Applicant Shantou T&K Medical Equipment Factory Co.,Ltd

K number K210380

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FXX 2021-07-08

Disposable Surgical Mask

Applicant Xiamen Eagledon Pharmaceutical Co., Ltd.

K number K210267

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FXX 2021-07-07

Surgical Mask

Applicant Changzhou Holymed Products Co., Ltd.

K number K210524

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FXX 2021-07-02

Single-use Medical Face Mask

Applicant Conod Medical Co., Limited

K number K203591

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FXX 2021-07-02

Disposable Surgical Mask

Applicant Xiamen Probtain Medical Techology Co., Ltd.

K number K202954

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FXX 2021-06-29

Nordiwell Surprotect Face Mask

Applicant Changzhou Combat Protective Equipment Co., Ltd.

K number K210445

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FXX 2021-06-22

Disposable Surgical Mask

Applicant Safeway Industry Healthcare.

K number K210840

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FXX 2021-06-16

Disposable Medical Surgical Face Mask

Applicant Guangdong Haiou Medical Apparatus Co., Ltd.

K number K203200

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FXX 2021-06-15

Amerishield Surgical Mask

Applicant Premiumestore, LLC

K number K211520

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FXX 2021-06-14

Surgical Face Mask

Applicant Shandong Haidike Medical Products Co., Ltd.

K number K210518

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FXX 2021-06-11

Surgical Face Mask

Applicant Zhuhai Gaoge Medical Technology Co., Ltd.

K number K203732

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FXX 2021-06-11

Medical Face Mask

Applicant Chongqing Chaoke Industry Development Co., Ltd.

K number K202714

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FXX 2021-06-10

Surgical Masks, Model:FE-1

Applicant Hunan Triplex Precision Medical Devices Co., Ltd.

K number K210767

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FXX 2021-06-10

Surgical Face Mask

Applicant Sample King Manufacturing, Ltd.

K number K210015

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FXX 2021-06-10

Disposable Surgical Mask

Applicant Lucky Textile Industrial(Wuxi) Co., Ltd.

K number K203756

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FXX 2021-06-08

Medical Face Mask

Applicant Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.

K number K211062

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FXX 2021-06-08

Disposable Surgical Mask

Applicant Shenzhen Peninsula Medical Co., Ltd.

K number K202126

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FXX 2021-06-07

Disposable Medical Mask

Applicant Tuosheng Protective Products (Ningbo) Co., Ltd.

K number K210641

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FXX 2021-06-07

Surgical Face Mask (Ear loops and Tie-on)

Applicant Wuhan Dymex Healthcare Co., Ltd.

K number K210433

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FXX 2021-06-07

Disposable Surgical Mask

Applicant Dongguan Shin YI Healthcare Products Factory

K number K210372

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FXX 2021-06-07

Disposable Surgical Mask

Applicant Qingdao Likangyuan Medical Device Co., Ltd.

K number K202580

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FXX 2021-06-04

Surgical face mask

Applicant Juntech(Jiaxing)Healthcare Materials Co,.Ltd

K number K203704

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FXX 2021-06-04

Disposable medical mask

Applicant Everwin Toys (Dongguan)., Ltd.

K number K203388

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FXX 2021-06-03

Allmed Surgical Face Masks (Ear loops)

Applicant Allmed Medical Products Co., Ltd.

K number K202128

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FXX 2021-06-02

ASM-301 Level 3 Surgical Mask

Applicant American Surgical Mask Company, LLC

K number K211440

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FXX 2021-06-02

Disposable Surgical Face Mask

Applicant Jiangxi Heying Pharmaceutical Co., Ltd.

K number K210429

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FXX 2021-06-02

Disposable Medical mask

Applicant Hubei Wanli Protective Products Co., Ltd.

K number K210150

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FXX 2021-06-02

Surgical Face Mask

Applicant Rfx+Care Manufactoring Co., Ltd.

K number K203190

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FXX 2021-05-25

AirMax Procedure Mask

Applicant Premiumestore, LLC

K number K211275

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FXX 2021-05-20

Procedure Mask, Surgical Mask

Applicant Kenpax International Limited

K number K202899

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FXX 2021-05-17

Ear-Friendly Mask

Applicant Ray Co., Ltd.

K number K211105

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FXX 2021-05-14

Disposable Medical mask

Applicant Anhui Jbh Medical Apparatus Co., Ltd.

K number K210302

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FXX 2021-05-13

Disposable Face Mask

Applicant Biobase Scientific (Shandong) Co., Ltd.

K number K210815

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FXX 2021-05-13

United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask

Applicant United Sewing Automation, Inc.

K number K202697

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FXX 2021-05-07

SURGICAL MASK, Model Name:C015

Applicant Qingdao Hainuo Biological Engineering Co., Ltd.

K number K210218

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FXX 2021-05-06

Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3

Applicant Defender Safety, Inc.

K number K210705

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FXX 2021-05-06

3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3

Applicant 3A Medical Products Co., Ltd.

K number K202598

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FXX 2021-05-04

Surgical Mask

Applicant Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z.

K number K210304

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FXX 2021-04-29

M1 Surgical Face Mask

Applicant CHISON Medical Technologies Co., Ltd.

K number K202457

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FXX 2021-04-28

Medical Mask

Applicant Zhende Medical Co., Ltd.

K number K210020

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FXX 2021-04-26

Surgical Mask

Applicant Ningbo Green Textile Co., Ltd.

K number K202647

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FXX 2021-04-23

Medical Surgical Mask

Applicant Tianjin Aoshang Outdoor Equipment Co., Ltd.

K number K210030

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FXX 2021-04-23

Face Mask

Applicant Jinhua Jingdi Medical Supplies Co., Ltd.

K number K210007

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FXX 2021-04-23

Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs

Applicant String King Lacrosse, LLC

K number K202607

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FXX 2021-04-23

Disposable Surgical Face Mask

Applicant Guangdong Bida Medical Technology Co., Ltd.

K number K202387

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FXX 2021-04-23

Naton Disposable Surgical Face Mask

Applicant Naton Biotechnology (Beijing) Co., Ltd.

K number K201853

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FXX 2021-04-22

Disposable Medical Face Mask

Applicant Guangzhou Mei YI Kang Medical Technology Co., Ltd.

K number K203646

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FXX 2021-04-21

Disposable medical surgical mask

Applicant Chongqing Coe Display Technology Co., Ltd.

K number K202759

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FXX 2021-04-15

GD Disposable Medical Face Mask

Applicant Jiangsu Guangda Medical Material Group Co., Ltd.

K number K201718

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FXX 2021-04-14

DEFEND Ear-loop Face Masks

Applicant Young Dental Manufacturing Co. 1, LLC

K number K201127

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FXX 2021-04-11

Disposable Medical Mask

Applicant Diasia Biomedical Technology Co., Ltd.

K number K210018

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FXX 2021-04-11

Surgical Mask

Applicant Customfab, Inc.

K number K203012

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FXX 2021-04-11

Medical Surgical Mask (Non-sterile)

Applicant Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.

K number K202761

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FXX 2021-04-09

Disposable Medical Face Mask-Model FM-04

Applicant Shenzhen Jinko Industrial Co., Ltd.

K number K202513

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FXX 2021-04-06

Disposable Surgical Face Mask

Applicant Anhui Jiabao Protective Equipments Co., Ltd.

K number K203801

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FXX 2021-04-05

Disposable Medical Mask

Applicant Dongguan Runlin Medical Supplies Technology Co., Ltd.

K number K202655

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FXX 2021-04-02

Surgical Face Mask

Applicant Guangdong Winsun Personal Care Products Co.,Ltd

K number K210023

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FXX 2021-03-31

Secure Wear USA Surgical Face Mask

Applicant Secured Ortho Manufacturing of America, LLC

K number K203101

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FXX 2021-03-31

Surgical Mask-Models CR02-2, CR02

Applicant Foshan Xinbao Technology Co., Ltd.

K number K202424

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FXX 2021-03-30

Surgical Face Masks

Applicant Intco Medical(Hk) Co., Ltd.

K number K202708

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FXX 2021-03-30

ivi N3003 Surgical face Mask, ivi N6006 Surgical mask

Applicant Iob Medical, Inc.

K number K201896

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FXX 2021-03-29

Surgical Mask

Applicant Wuhan Zonsen Medical Products Co., Ltd.

K number K202191

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FXX 2021-03-26

Disposable Surgical Face Mask

Applicant Xiantao Zhongyi Safety & Protection Products Co., Ltd.

K number K203685

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FXX 2021-03-26

Disposable Face Mask

Applicant Jiangsu Excellence Medical Supplies Co., Ltd.

K number K202905

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