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510(k) Data Aggregation
K Number
K212812Device Name
Surgical Gown
Manufacturer
Date Cleared
2022-11-16
(439 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xianning Marveldas Protective Articles CO.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical gowns are sterile, disposable, and single use devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. This device is sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135 (2014).
Device Description
The Sterile Level 4 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use and EO sterilized. The Sterile Level 4 Surgical Gowns are available in five models including S、 M、L、XL and XXL. The proposed surgical are constructed of a SMS nonwoven material (SMS+Film covering material+Velcro tape+Cuff material) and it is a kind of reinforced surgical gown and blue color.
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