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510(k) Data Aggregation
K Number
K102692Device Name
SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
Date Cleared
2011-03-11
(172 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
HANGZHOU JINCHENG MEDICAL SUPPLIER MANUFACTURE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Jincheng Surgical Gown is a single use, sterile or none sterile (sterile before use) item that is intended to be used in operation room as a protective covering, for operating room staff, from the transferring of body fluids and particulates.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Device Description
The Jincheng Surgical Gowns are an open back gown manufactured from nonwoven fabric that the fibres are mechanically bonded together. They are full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. They come with three different types of materials (SMS polypropylene fabric, Spunlace fabric, and SFT fabric) and four different design styles (regular, reinforced, regular with guider, and reinforced with guider). Therefore there are total eight different models involved in this submission. They are: Jincheng SMS Gowns (SMS Reinforced Gown, SMS Reinforced Gown with Guider), Jincheng Spunlace Gowns (Spunlace Regular Gown, Spunlace Regular Gown with Guider, Spunlace Reinforced Gown, Spunlace Reinforced Gown with Guider), Jincheng SFT Gowns (SFT Gown, SFT Gown with Guider). Each design has four different sizes: Medium (M), Large (L), Extra Large (XL), and Extra Extra Large (XXL). All gowns come with sterile and non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
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