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510(k) Data Aggregation
K Number
K220435Device Name
SEJONG Surgical Gown Soft
Manufacturer
Date Cleared
2023-02-10
(361 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Sejong Healthcare Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SEJONG Surgical Gown Soft is sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The SEJONG Surgical Gown Soft meets the Level 3 requirements of ANSI/AAMI PB70:2012. Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The SEIONG Surgical Gown Soft has been validated using ethylene oxide (EtO) sterilization process. The SEJONG Surgical Gown Soft is also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EO sterilization method according to ISO 11135 prior to being provided to the end user.
Device Description
The SEJONG Level 3 Surgical Gowns is a non-reinforced design and available in 4 sizes ranging from medium to XX-large. Below Table provides model number of the Sejong Surgical Gown Soft. The chest and sleeve critical zones, as well as the overall body, are constructed from a blue polyolefin/polypropylene SMMMS (Spunbound, meltblown, meltblown, spunbound). Sejong Surgical Gown Soft has been tested according to ANSI/AAMI PB70:2012 and meets and AAMI Level 3 barrier level protection for a surgical gown. Sejong Surgical Gown Soft is nonreinforced, single use, disposable medical device that will be provided in both a sterile packaging configuration and a variety of sizes.
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