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510(k) Data Aggregation
K Number
K201991Device Name
Medical surgical mask
Manufacturer
Date Cleared
2020-11-23
(129 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Everwin Precision Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood fluids. This is a single-use, disposable device, provided non-sterile.
Device Description
The medical surgical mask is designed and manufactured by Shenzhen Everwin Precision Technology Co, Ltd. It is non-sterile and for single use. It's a disposable device. The medical surgical mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elasticear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire.
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