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510(k) Data Aggregation
K Number
K203704Device Name
Surgical face mask
Manufacturer
Date Cleared
2021-06-04
(168 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Juntech(Jiaxing)Healthcare Materials 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
Surgical Face Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. Earloops are of urethane elastic fiber and not made with natural rubber latex; The nose piece is a white aluminum strip covered by PP covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices.
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