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510(k) Data Aggregation
K Number
K201698Device Name
Medical Surgical Mask
Manufacturer
Date Cleared
2021-03-15
(266 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Mycode Bio-Medicine Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
Device Description
Medical Surgical Masks are disposable medical masks and are made of mask body, nose clips and mask belt by ultrasonic heat sealing. The mask body is divided into three layers: inner, middle and outer layers, the inner and outer layers are Non-woven fabrics and middle layer is polypropylene melt blown cloth, nose piece is made of galvanized iron wire covered plastic materials. The mask belt is made of spandex. The mask style is flat pleated.
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