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510(k) Data Aggregation
K Number
K203161Device Name
Surgical Face Mask
Manufacturer
Date Cleared
2022-01-20
(454 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Raytex Protection CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.
Device Description
The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.
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