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510(k) Data Aggregation
K Number
K202904Device Name
Surgical Face Mask
Manufacturer
Date Cleared
2021-01-21
(114 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Jiangxi Feilikang Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Device Description
The proposed device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric. The ear loops, which are made of nylon and spandex, are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.
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