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510(k) Data Aggregation
K Number
K210102Device Name
Topwide Surgical Face Mask
Manufacturer
Date Cleared
2021-12-17
(337 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Topwide (Hubei) Medical Products Manufacturer
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TOPWIDE surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.
Device Description
The Topwide surgical face mask is with white color outer laver and white inner layer. Subject device is a Flat Pleated type mask, utilizing ear-loop way for wearing, and it has a nose piece design for fitting the facemask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner laver (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask has Level II fluid resistance under ASTM F2100. The mask is a single use, provided non sterile. This product contains no components made with natural rubber latex.
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