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510(k) K102692

Device
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
Applicant
HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO.
510(k) number
K102692
Product code
FYA  
Decision
Substantially Equivalent (SESE)
Decision date
2011-03-11
Date received
2010-09-20
Regulation
878.4040
Classification name
Gown, 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
CHENGYU SHEN
Address
5 Carey St. Pennington NJ US 08534 08534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FYA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.2026-05-12
K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, LLC2026-04-28
K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)Hubei Xinxin Non-Woven Co., Ltd.2026-04-20
K251860Copioumed AAMI 3 Surgical GownCopioumed International, Inc.2026-02-26
K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)Yadu Medical (Henan) Co., Ltd.2026-02-04
K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.2025-12-03
K243522ViVi® Toga PremiumThi Total Healthcare Innovation GmbH2025-05-30
K242937Dream Medi Sterile Surgical Gown (SurgicalGownUL)Dae Myung Chemical Co., Ltd. (Vietnam)2025-05-05
K242844Medline Level 4 Surgical Gown with Breathable SleevesMedline Industries, LP2025-02-26
K241272Stryker Steri-Shield 8 Surgical Hoods and TogasStryker Instruments2024-10-16
K241214ProPel SG3™ Surgical GownStandard Textile Co., Inc.2024-09-10
K233571GCI Surgical GownGeorge Courey, Inc.2024-08-02
K233068Disposable Surgical GownNanning Tecbod Biological Technology Co., Ltd.2024-03-29
K233183Surgical Gown (40083)Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.2024-02-01
K230707Skypro, Surgical Gown 6021Skypro Medical Supplies Company2023-10-12

Legacy Summary#

summary

FDA Review#

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