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510(k) K201537

Device
Protective Face Mask For Medical Use
Applicant
Shandong Shengquan New Material Co., Ltd.
510(k) number
K201537
Product code
MSH  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-04
Date received
2020-06-08
Regulation
878.4040
Classification name
Respirator, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xiumei Zhang
Address
Diaozhen Industrial Development Zone, Zhangqiu District Jinan CN 250204 250204

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallOwens & Minor (O&M) Halyard, Inc.2024-01-12
K172963Master-Frank N95 Particulate RespiratorMaster & Frank Enterprise Co., Ltd.2018-04-04
K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S3M Healthcare2017-08-10
K160271N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12San-M Package Co., Ltd.2016-07-15
K141876Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 RespiratorPasture Pharma Pte, Ltd.2015-10-28
K1210693M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK3M Company2013-02-11
K102923BARRIER N95 PARTICULATE RESPIRATORMolnlycke Health Care2010-11-19
K102092PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIESPrestige Ameritech2010-10-06
K102173MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712Moldex/Metric, Inc.2010-09-13
K100139SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150Safelife Corp.2010-05-04
K092824N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695Alpha Protech, Inc.2009-10-21
K090131DS N95 SURGICAL MASKS AND FLAT SURGICALShanghai Dasheng Health Products2009-04-27
K080827HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810Handan Hengyong Protective & Clean Products Co., L2008-04-04
K072067N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028Shuenn Bao Shing Corporation2008-01-08
K072359AEARO COMPANY SURGICAL N95 RESPIRATORS, MODELS N9508C AND N9511CAearo Company2007-11-08

Legacy Summary#

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FDA Review#

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