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510(k) Data Aggregation
K Number
K220665Device Name
Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
Manufacturer
Date Cleared
2022-06-03
(88 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Excellent Medical Technology Group Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical Gown, Blue, Sterile and Surgical Gown, Blue, Non-Sterile intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EiO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
The Surgical Gowns meet the Level 3 ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.
Device Description
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